Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-27 @ 11:13 PM
Study NCT ID:
NCT01537094
Status:
WITHDRAWN
Last Update Posted:
2013-12-13
First Post:
2012-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Vitamin C on Growth Hormone Secretion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001205', 'term': 'Ascorbic Acid'}], 'ancestors': [{'id': 'D013400', 'term': 'Sugar Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Unable to obtain funding to initiate the study. No subjects were enrolled.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-11', 'studyFirstSubmitDate': '2012-02-10', 'studyFirstSubmitQcDate': '2012-02-16', 'lastUpdatePostDateStruct': {'date': '2013-12-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in GH secretion at 4 weeks', 'timeFrame': 'Change from Baseline to 4 weeks', 'description': 'GH secretion will be assessed by overnight frequent blood sampling to assess maximum GH, nadir GH, mean overnight GH, as well as parameters of pulsatile secretion.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['low vitamin c', 'reduced growth hormone secretion'], 'conditions': ['Obese', 'Disorder of Vitamin C', 'Growth Hormone Secretion Abnormality']}, 'descriptionModule': {'briefSummary': 'Obesity is associated with reduced growth hormone (GH) secretion. GH secretion is regulated by nutritional stimuli including fasting, insulin, glucose and free fatty acids. However, the role of micronutrients, such as vitamins, on GH secretion has not been investigated in much detail. Vitamin C levels are also reduced in obesity, and the investigators recently demonstrated a possible role for dietary vitamin C intake in the regulation of GH secretion in two preliminary retrospective studies. The investigators therefore propose a more detailed prospective physiological study to examine the effects of increasing dietary vitamin C intake on GH secretion in a physiologic, intervention study. The investigators hypothesize that increasing vitamin C concentrations in obese subjects with sub-optimal plasma vitamin C levels and reduced GH secretion will increase GH secretion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Men and women age 18-60\n2. BMI ≥ 30 kg/m2\n3. Waist circumference ≥ 102 cm in men and ≥ 88 cm in women\n4. Plasma vitamin C concentration ≤ 23 µmol/l\n5. Peak stimulated GH ≤ 4.2 µg/l upon GHRH-arginine stimulation test\n\nExclusion Criteria:\n\n1. History of hypopituitarism, pituitary surgery, pituitary/brain radiation, recent traumatic brain injury or any other condition known to affect the GH axis.\n2. History of severe chronic illness including anemia, chronic kidney disease, liver disease, oxygen dependent COPD or HIV\n3. Subjects on testosterone, glucocorticoids, anabolic steroids, GHRH, GH or IGF-1 within 3 months of enrollment\n4. Use of dietary supplements including vitamin C or once daily multi-vitamins\n5. Subjects with Hgb \\< 912 g/dL, SGOT \\> 2.5x upper limit of normal or Creatinine \\> 1.5 mg/dL\n6. Subjects with poorly controlled diabetes, defined as HbA1c \\> 8%.\n7. Changes in lipid lowering or anti-hypertensive regimen within 3months of screening\n8. Subject is currently enrolled in another investigational device or drug trial(s), or subject has received other investigational agent(s) within 28 days of baseline visit\n9. Any condition judged by the patient's physician to cause this clinical trial to be detrimental to the patient."}, 'identificationModule': {'nctId': 'NCT01537094', 'briefTitle': 'The Effect of Vitamin C on Growth Hormone Secretion', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'The Effect of Vitamin C on Growth Hormone Secretion', 'orgStudyIdInfo': {'id': '2011-P-002912'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Vitamin C low dose', 'description': 'vitamin C 250 mg oral once daily', 'interventionNames': ['Dietary Supplement: Vitamin C 250 mg once daily']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vitamin C high dose', 'description': 'vitamin C 1,000 mg oral once daily', 'interventionNames': ['Dietary Supplement: Vitamin C 1,000 mg once daily']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo oral once daily', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Placebo']}, {'name': 'Vitamin C 250 mg once daily', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Vitamin C low dose']}, {'name': 'Vitamin C 1,000 mg once daily', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Vitamin C high dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Hideo Makimura, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine', 'investigatorFullName': 'Hideo Makimura', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}