Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2026-01-02 @ 10:53 AM
Study NCT ID:
NCT02942732
Status:
COMPLETED
Last Update Posted:
2016-10-24
First Post:
2016-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vitamin D Supplementation and Glycemic Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2018-09-13', 'releaseDate': '2018-01-12'}], 'estimatedResultsFirstSubmitDate': '2018-01-12'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002762', 'term': 'Cholecalciferol'}], 'ancestors': [{'id': 'D002782', 'term': 'Cholestenes'}, {'id': 'D002776', 'term': 'Cholestanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013261', 'term': 'Sterols'}, {'id': 'D014807', 'term': 'Vitamin D'}, {'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-21', 'studyFirstSubmitDate': '2016-10-16', 'studyFirstSubmitQcDate': '2016-10-21', 'lastUpdatePostDateStruct': {'date': '2016-10-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-10-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fasting blood glucose (mmol/l)', 'timeFrame': 'Baseline and 6 months', 'description': 'Change in Fasting blood glucose in mmol/l'}, {'measure': 'HbA1C (%)', 'timeFrame': 'Baseline and 6 months', 'description': 'Change in HbA1C (%)'}, {'measure': 'HOMA-IR', 'timeFrame': 'Baseline and 6 months', 'description': 'Change in HOMA-IR'}, {'measure': 'Fasting Insulin (mIU/L)', 'timeFrame': 'Baseline and 6 months', 'description': 'Change in Fasting Insulin (mIU/L)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Vitamin D', 'Glucose', 'HbA1C', 'Insulin resistance', 'Blood lipids'], 'conditions': ['Insulin Resistance']}, 'referencesModule': {'references': [{'pmid': '19125756', 'type': 'RESULT', 'citation': 'Nagpal J, Pande JN, Bhartia A. A double-blind, randomized, placebo-controlled trial of the short-term effect of vitamin D3 supplementation on insulin sensitivity in apparently healthy, middle-aged, centrally obese men. Diabet Med. 2009 Jan;26(1):19-27. doi: 10.1111/j.1464-5491.2008.02636.x.'}, {'pmid': '17389701', 'type': 'RESULT', 'citation': 'Pittas AG, Lau J, Hu FB, Dawson-Hughes B. The role of vitamin D and calcium in type 2 diabetes. A systematic review and meta-analysis. J Clin Endocrinol Metab. 2007 Jun;92(6):2017-29. doi: 10.1210/jc.2007-0298. Epub 2007 Mar 27.'}]}, 'descriptionModule': {'briefSummary': 'The investigators examined the effect of vitamin D supplementation on glucose homeostasis and metabolic markers in healthy normal weight and overweight young subjects and healthy normal-weight and overweight elderly subjects living in Beirut, Lebanon.', 'detailedDescription': 'A low serum 25-hydroxyvitamin D (25(OH)D) concentration has been shown to correlate with higher fasting blood glucose (FBG) and insulin levels and other metabolic abnormalities like dyslipidemia. Previous studies suggest that vitamin D supplementation is able to improve insulin sensitivity and metabolic markers. The aim of the study was to investigate the effect of vitamin D supplementation on glucose homeostasis and metabolic markers in healthy normal weight and overweight young subjects and healthy normal-weight and overweight elderly subjects living in Beirut, Lebanon. Participants (n= 180; 93 men and 87 women) deficient in vitamin D were recruited from Saint Charles Hospital, Beirut, Lebanon. Four groups were recruited: normal-weight adults (n=30, age ≤ 65 years and BMI \\< 25 kg/m²), overweight adults (n=30, age ≤ 65 years and BMI ≥ 25 kg/m²), normal-weight elderly (n=60, age ≥ 65 years and BMI \\< 25 kg/m²) and overweight elderly (n=60, age ≥ 65 years and BMI ≥ 25 kg/m²).\n\nParticipants received a supplement of 10,000 IU cholecalciferol to be taken three times per week for a period of 6 months. Glucose homeostasis and metabolic markers were measured at start of treatment, at 3 months and at 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants with no medical history of congestive heart failure, acute heart insufficiency and renal failure were included\n\nExclusion Criteria:\n\n* Participants with medical history of congestive heart failure, acute heart insufficiency and renal failure were excluded'}, 'identificationModule': {'nctId': 'NCT02942732', 'briefTitle': 'Vitamin D Supplementation and Glycemic Outcomes', 'organization': {'class': 'OTHER', 'fullName': "Université d'Auvergne"}, 'officialTitle': 'Effect of Treating Vitamin D Deficiency on Glucose Homeostasis and Metabolic Markers in Apparently Healthy, Young or Aged, Normal-weight or Obese Lebanese People', 'orgStudyIdInfo': {'id': 'UAuvergne'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'normal-weight adult subjects', 'description': 'normal-weight adult subjects (n=30, age ≤ 65 years and BMI ≤ 25 kg/m²) All assigned patients received a supplement of 10,000 IU cholecalciferol (Euro-Pharm International, Canada) to be taken three times per week. The treatment was led for a period of 6 months.', 'interventionNames': ['Dietary Supplement: cholecalciferol (Euro-Pharm International, Canada)']}, {'type': 'OTHER', 'label': 'overweight adult subjects', 'description': 'overweight adult subjects (n=30, age ≤ 65 years and BMI ≥ 25 kg/m²) All assigned patients received a supplement of 10,000 IU cholecalciferol (Euro-Pharm International, Canada) to be taken three times per week. The treatment was led for a period of 6 months.', 'interventionNames': ['Dietary Supplement: cholecalciferol (Euro-Pharm International, Canada)']}, {'type': 'OTHER', 'label': 'normal-weight elderly', 'description': 'normal-weight elderly (n=60, age ≥ 65 years and BMI ≤ 25 kg/m²) All assigned patients received a supplement of 10,000 IU cholecalciferol (Euro-Pharm International, Canada) to be taken three times per week. The treatment was led for a period of 6 months.', 'interventionNames': ['Dietary Supplement: cholecalciferol (Euro-Pharm International, Canada)']}, {'type': 'OTHER', 'label': 'overweight elderly', 'description': 'overweight elderly (n=60, age ≥ 65 years and BMI ≥ 25 kg/m²) All assigned patients received a supplement of 10,000 IU cholecalciferol (Euro-Pharm International, Canada) to be taken three times per week. The treatment was led for a period of 6 months.', 'interventionNames': ['Dietary Supplement: cholecalciferol (Euro-Pharm International, Canada)']}], 'interventions': [{'name': 'cholecalciferol (Euro-Pharm International, Canada)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'All assigned patients received a supplement of 10,000 IU cholecalciferol (Euro-Pharm International, Canada) to be taken three times per week. The treatment was led for a period of 6 months.', 'armGroupLabels': ['normal-weight adult subjects', 'normal-weight elderly', 'overweight adult subjects', 'overweight elderly']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Stephane Walrand, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Auvergne Univeristy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Université d'Auvergne", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2018-01-12', 'type': 'RELEASE'}, {'date': '2018-09-13', 'type': 'RESET'}], 'unpostedResponsibleParty': "Université d'Auvergne"}}}}