Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2026-03-02 @ 6:08 PM
Study NCT ID:
NCT01447433
Status:
COMPLETED
Last Update Posted:
2012-08-01
First Post:
2011-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Calcium + Vitamin D Supplementation on Weight Management in Very-low Calcium Consumers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D001835', 'term': 'Body Weight'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002119', 'term': 'Calcium Carbonate'}, {'id': 'C007792', 'term': 'Fumigant 93'}], 'ancestors': [{'id': 'D017610', 'term': 'Calcium Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D002254', 'term': 'Carbonates'}, {'id': 'D002255', 'term': 'Carbonic Acid'}, {'id': 'D017554', 'term': 'Carbon Compounds, Inorganic'}, {'id': 'D008903', 'term': 'Minerals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nutrition1226@126.com', 'phone': '86 21 81873168', 'title': 'Prof. Donglian Cai', 'organization': 'Changhai Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'The study sample was mostly women.'}}, 'adverseEventsModule': {'timeFrame': '12 weeks', 'description': 'Adverse event was assessed by questionnaires during biweekly interviews with dietitians throughout the program.', 'eventGroups': [{'id': 'EG000', 'title': 'Calcium+D', 'description': 'Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.', 'otherNumAtRisk': 26, 'otherNumAffected': 0, 'seriousNumAtRisk': 26, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.', 'otherNumAtRisk': 27, 'otherNumAffected': 0, 'seriousNumAtRisk': 27, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Calcium+D', 'description': 'Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.'}, {'id': 'OG001', 'title': 'Control', 'description': 'A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.9', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '-3.5', 'spread': '1.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.441', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.439', 'ciLowerLimit': '-0.70', 'ciUpperLimit': '1.58', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.56', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Weight was obtained in light clothing to the nearest 0.1kg using a digital scale 8:00am and 10:00am after an overnight fast between.', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Males were excluded from final analysis for statistical reasons.'}, {'type': 'SECONDARY', 'title': 'Change in Body Fat Mass，Body Lean Mass and Visceral Fat Mass', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Calcium+D', 'description': 'Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.'}, {'id': 'OG001', 'title': 'Control', 'description': 'A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.'}], 'classes': [{'title': 'Body Fat Mass', 'categories': [{'measurements': [{'value': '-2.8', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '-1.9', 'spread': '1.3', 'groupId': 'OG001'}]}]}, {'title': 'Body Lean Mass', 'categories': [{'measurements': [{'value': '-0.9', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'Visceral Fat Mass', 'categories': [{'measurements': [{'value': '-0.47', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '-0.29', 'spread': '0.21', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.038', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.88', 'ciLowerLimit': '0.05', 'ciUpperLimit': '1.70', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.41', 'groupDescription': 'Body Fat Mass', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.082', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.50', 'ciLowerLimit': '-1.06', 'ciUpperLimit': '0.07', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.28', 'groupDescription': 'Body Lean Mass', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.018', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.18', 'ciLowerLimit': '0.03', 'ciUpperLimit': '0.32', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.07', 'groupDescription': 'Visceral Fat Mass', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'BIA (bioelectric impedance analysis, ZEUS9.9, JAWON) was used to determine body fat mass, body lean mass, and visceral fat mass.', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Males were excluded from final analysis for statistical reasons.'}, {'type': 'SECONDARY', 'title': 'Change in Fat Percentage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Calcium+D', 'description': 'Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.'}, {'id': 'OG001', 'title': 'Control', 'description': 'A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.6', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '1.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.031', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.10', 'ciLowerLimit': '0.10', 'ciUpperLimit': '2.09', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.49', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'BIA (bioelectric impedance analysis, ZEUS9.9, JAWON) was used to determine fat percentage.', 'unitOfMeasure': 'Percentage of body weight', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Males were excluded from final analysis for statistical reasons.'}, {'type': 'SECONDARY', 'title': 'Change in Visceral Fat Area', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Calcium+D', 'description': 'Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.'}, {'id': 'OG001', 'title': 'Control', 'description': 'A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.'}], 'classes': [{'categories': [{'measurements': [{'value': '-12.5', 'spread': '6.2', 'groupId': 'OG000'}, {'value': '-6.8', 'spread': '7.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.016', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.72', 'ciLowerLimit': '1.15', 'ciUpperLimit': '10.29', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.25', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'BIA (bioelectric impedance analysis, ZEUS9.9, JAWON) was used to determine visceral fat area.', 'unitOfMeasure': 'cm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Males were excluded from final analysis for statistical reasons.'}, {'type': 'SECONDARY', 'title': 'Change in Waist, Abdominal and Hip Circumference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Calcium+D', 'description': 'Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.'}, {'id': 'OG001', 'title': 'Control', 'description': 'A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.'}], 'classes': [{'title': 'Waist Circumference', 'categories': [{'measurements': [{'value': '-6.2', 'spread': '5.7', 'groupId': 'OG000'}, {'value': '-5.1', 'spread': '5.0', 'groupId': 'OG001'}]}]}, {'title': 'Abdominal Circumference', 'categories': [{'measurements': [{'value': '-4.6', 'spread': '4.4', 'groupId': 'OG000'}, {'value': '-5.8', 'spread': '8.3', 'groupId': 'OG001'}]}]}, {'title': 'Hip Circumference', 'categories': [{'measurements': [{'value': '-4.2', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '-3.2', 'spread': '2.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.508', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.14', 'ciLowerLimit': '-2.31', 'ciUpperLimit': '4.58', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.70', 'groupDescription': 'Waist Circumference', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.560', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.22', 'ciLowerLimit': '-5.42', 'ciUpperLimit': '2.98', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.07', 'groupDescription': 'Abdominal Circumference', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.255', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '-0.74', 'ciUpperLimit': '2.70', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.85', 'groupDescription': 'Hip Circumference', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Waist, abdominal and hip circumference was measured using a plastic tape to the nearest 0.1 cm', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Males were excluded from final analysis for statistical reasons.'}, {'type': 'SECONDARY', 'title': 'Change in Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Calcium+D', 'description': 'Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.'}, {'id': 'OG001', 'title': 'Control', 'description': 'A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.'}], 'classes': [{'title': 'Systolic Blood Pressure', 'categories': [{'measurements': [{'value': '-8.3', 'spread': '13.2', 'groupId': 'OG000'}, {'value': '-12.1', 'spread': '13.7', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic Blood Pressure', 'categories': [{'measurements': [{'value': '-6.0', 'spread': '9.8', 'groupId': 'OG000'}, {'value': '-5.0', 'spread': '9.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.404', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.8', 'ciLowerLimit': '-12.9', 'ciUpperLimit': '5.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.5', 'groupDescription': 'Systolic Blood Pressure', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.768', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.94', 'ciLowerLimit': '-5.52', 'ciUpperLimit': '7.41', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.18', 'groupDescription': 'Diastolic Blood Pressure', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Systolic and diastolic blood pressures were measured in the left arm at heart level of subjects seated for a minimum of 5 minutes using mercurial sphygmomanometer.', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Males were excluded from final analysis for statistical reasons.'}, {'type': 'SECONDARY', 'title': 'Change in Lipid-lipoprotein Profile', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Calcium+D', 'description': 'Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.'}, {'id': 'OG001', 'title': 'Control', 'description': 'A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.'}], 'classes': [{'title': 'TC', 'categories': [{'measurements': [{'value': '-0.11', 'spread': '0.43', 'groupId': 'OG000'}, {'value': '-0.19', 'spread': '0.45', 'groupId': 'OG001'}]}]}, {'title': 'TG', 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.42', 'groupId': 'OG000'}, {'value': '0.10', 'spread': '0.55', 'groupId': 'OG001'}]}]}, {'title': 'HDL', 'categories': [{'measurements': [{'value': '0.12', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '-0.14', 'spread': '0.48', 'groupId': 'OG001'}]}]}, {'title': 'LDL', 'categories': [{'measurements': [{'value': '0.14', 'spread': '0.51', 'groupId': 'OG000'}, {'value': '0.12', 'spread': '0.40', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.565', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.08', 'ciLowerLimit': '-0.36', 'ciUpperLimit': '0.20', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.14', 'groupDescription': 'TC', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.636', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.07', 'ciLowerLimit': '-0.24', 'ciUpperLimit': '0.39', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.15', 'groupDescription': 'TG', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.112', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.26', 'ciLowerLimit': '-0.58', 'ciUpperLimit': '0.06', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.16', 'groupDescription': 'HDL', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.647', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.02', 'ciLowerLimit': '-0.11', 'ciUpperLimit': '0.05', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.15', 'groupDescription': 'LDL', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Males were excluded from final analysis for statistical reasons.'}, {'type': 'SECONDARY', 'title': 'Change in Fasting Plasma Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Calcium+D', 'description': 'Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.'}, {'id': 'OG001', 'title': 'Control', 'description': 'A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.25', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '0.37', 'spread': '0.37', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.260', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.13', 'ciLowerLimit': '-0.10', 'ciUpperLimit': '0.35', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.11', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Males were excluded from final analysis for statistical reasons.'}, {'type': 'SECONDARY', 'title': 'Change in Fasting Plasma Insulin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Calcium+D', 'description': 'Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.'}, {'id': 'OG001', 'title': 'Control', 'description': 'A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.18', 'spread': '5.02', 'groupId': 'OG000'}, {'value': '-0.31', 'spread': '5.16', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.598', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.87', 'ciLowerLimit': '-2.44', 'ciUpperLimit': '4.17', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.63', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'unitOfMeasure': 'mIU/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Males were excluded from final analysis for statistical reasons.'}, {'type': 'SECONDARY', 'title': 'Change in Energy Intakes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Calcium+D', 'description': 'Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.'}, {'id': 'OG001', 'title': 'Control', 'description': 'A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.'}], 'classes': [{'categories': [{'measurements': [{'value': '-400.4', 'spread': '252.0', 'groupId': 'OG000'}, {'value': '-301.9', 'spread': '310.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.275', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '98.5', 'ciLowerLimit': '-81.6', 'ciUpperLimit': '278.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '89.0', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'unitOfMeasure': 'kcal/d', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Males were excluded from final analysis for statistical reasons.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Calcium+D', 'description': 'Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.'}, {'id': 'FG001', 'title': 'Control', 'description': 'A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participant were recruited through informational flyers and advertisements posted on campus of colleges and vocational schools in Pudong and Yangpu Districts in Shanghai, China. From April 20th to September 20th, 2011, a total of 129 out of 187 volunteers who answered our recruitment advertisements were invited for a pre-screening interview.', 'preAssignmentDetails': 'The pre-screening FFQ excluded 34 volunteers for habitual calcium intake\\>600mg/day. During screening, 16 were excluded for BMI\\<24kg/m2, 3 reported for using calcium supplements, 14 were on a diet, 2 refused to take calcium supplements, 1 refused to being taken blood samples, and 6 failed to sign the informed consents for personal reasons.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Calcium+D', 'description': 'Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.'}, {'id': 'BG001', 'title': 'Control', 'description': 'A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '20.3', 'spread': '1.4', 'groupId': 'BG000'}, {'value': '20.4', 'spread': '0.8', 'groupId': 'BG001'}, {'value': '20.3', 'spread': '1.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-26', 'studyFirstSubmitDate': '2011-10-04', 'resultsFirstSubmitDate': '2012-01-03', 'studyFirstSubmitQcDate': '2011-10-04', 'lastUpdatePostDateStruct': {'date': '2012-08-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-02-01', 'studyFirstPostDateStruct': {'date': '2011-10-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-03-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Body Weight', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Weight was obtained in light clothing to the nearest 0.1kg using a digital scale 8:00am and 10:00am after an overnight fast between.'}], 'secondaryOutcomes': [{'measure': 'Change in Body Fat Mass，Body Lean Mass and Visceral Fat Mass', 'timeFrame': 'Baseline and 12 weeks', 'description': 'BIA (bioelectric impedance analysis, ZEUS9.9, JAWON) was used to determine body fat mass, body lean mass, and visceral fat mass.'}, {'measure': 'Change in Fat Percentage', 'timeFrame': 'Baseline and 12 weeks', 'description': 'BIA (bioelectric impedance analysis, ZEUS9.9, JAWON) was used to determine fat percentage.'}, {'measure': 'Change in Visceral Fat Area', 'timeFrame': 'Baseline and 12 weeks', 'description': 'BIA (bioelectric impedance analysis, ZEUS9.9, JAWON) was used to determine visceral fat area.'}, {'measure': 'Change in Waist, Abdominal and Hip Circumference', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Waist, abdominal and hip circumference was measured using a plastic tape to the nearest 0.1 cm'}, {'measure': 'Change in Blood Pressure', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Systolic and diastolic blood pressures were measured in the left arm at heart level of subjects seated for a minimum of 5 minutes using mercurial sphygmomanometer.'}, {'measure': 'Change in Lipid-lipoprotein Profile', 'timeFrame': 'Baseline and 12 weeks'}, {'measure': 'Change in Fasting Plasma Glucose', 'timeFrame': 'Baseline and 12 weeks'}, {'measure': 'Change in Fasting Plasma Insulin', 'timeFrame': 'Baseline and 12 weeks'}, {'measure': 'Change in Energy Intakes', 'timeFrame': 'Baseline and 12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Calcium Carbonate', 'Vitamin D', 'Body weight', 'Body fat', 'Metabolic parameters', 'Energy restriction', 'Very-low calcium consumers', 'Obesity', 'Overweight'], 'conditions': ['Obesity', 'Overweight']}, 'referencesModule': {'references': [{'pmid': '23297844', 'type': 'DERIVED', 'citation': 'Zhu W, Cai D, Wang Y, Lin N, Hu Q, Qi Y, Ma S, Amarasekara S. Calcium plus vitamin D3 supplementation facilitated fat loss in overweight and obese college students with very-low calcium consumption: a randomized controlled trial. Nutr J. 2013 Jan 8;12:8. doi: 10.1186/1475-2891-12-8.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine whether calcium plus vitamin D supplementation is conducive to weight and fat loss during energy restriction in very-low calcium consumers.', 'detailedDescription': 'Due to the contradicting findings in the hypothesis of calcium supplementation on weight and fat loss, which might be explained by the difference in initial calcium intake, the present study is aimed to evaluate the effect of calcium plus vitamin D supplementation on accelerating weight and fat loss in overweight or obese subjects with very-low calcium consumption(\\<600mg/day).\n\nThe hypotheses to be tested are:\n\nCalcium plus vitamin D supplementation is conducive to body weight and fat loss in overweight or obese young adults during energy restriction 12 weeks after randomization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female 18 to 25 years of age, generally healthy\n* Habitual calcium intake below 600mg/d\n* Overweight or obese (BMI between 24 and 35kg/m2, refer to the Chinese standard)\n* Stable body weight (body weight change less than 1kg two months before screening)\n* Less than 3 times of 20min of physical exercise per week\n* Signed written informed consent\n\nExclusion Criteria:\n\n* Coronary heart disease, hypertension, diabetes; hepatic insufficiency or renal insufficiency, hyper- or hypothyroidism, mal-absorption, cholesterol concentrations requiring pharmaceutical treatment\n* Pregnant or lactating woman\n* Use of calcium supplements, oral antidiabetic agents, antihyperlipidemics or any other medications affecting metabolism 30 days before randomization\n* Participating in another weight loss programs (i.e. taking oral pharmacotherapeutic agents and/or herbal preparations intended for the management of obesity; excessive physical activity; be on a diet)\n* On special diets (i.e. vegetarian)\n* Presently taking or have recently taken a prescription drug such as fluoroquinolone antibiotics, tetracycline, or levothyroxine (thyroid medication)\n* Participating in another clinical trial 6 months before randomization\n* Unlikely to be compliant (i.e. alcohol, drug abuse)\n* Refusal or inability to give informed consent to participate in the study'}, 'identificationModule': {'nctId': 'NCT01447433', 'briefTitle': 'Effect of Calcium + Vitamin D Supplementation on Weight Management in Very-low Calcium Consumers', 'organization': {'class': 'OTHER', 'fullName': 'Changhai Hospital'}, 'officialTitle': 'A Randomized, Open-label, Parallel Groups-controlled Clinical Trial to Evaluate the Effect of Calcium Plus Vitamin D Supplementation on Weight Management in Overweight and Obese Very-low Calcium Consumers', 'orgStudyIdInfo': {'id': '201011Z-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Calcium+D', 'description': 'Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.', 'interventionNames': ['Drug: Calcium Carbonate', 'Behavioral: Energy restriction']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.', 'interventionNames': ['Behavioral: Energy restriction']}], 'interventions': [{'name': 'Calcium Carbonate', 'type': 'DRUG', 'otherNames': ['Caltrate® 600 + D', 'Code:1007300'], 'description': 'tablet, 600mg elemental calcium and 125IU vitamin D, once daily, for 12 weeks', 'armGroupLabels': ['Calcium+D']}, {'name': 'Energy restriction', 'type': 'BEHAVIORAL', 'description': 'A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.', 'armGroupLabels': ['Calcium+D', 'Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200433', 'city': 'Shanghai', 'country': 'China', 'facility': 'Changhai Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Donglian Cai, Master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Changhai Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Changhai Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Donglian Cai', 'investigatorAffiliation': 'Changhai Hospital'}}}}