The Effect of Vitamin C on Growth Hormone Secretion
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| First Received Date ICMJE | February 10, 2012 | ||||
| Last Updated Date | March 5, 2013 | ||||
| Start Date ICMJE | September 2013 | ||||
| Estimated Primary Completion Date | September 2016 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Change from Baseline in GH secretion at 4 weeks [ Time Frame: Change from Baseline to 4 weeks ] [ Designated as safety issue: No ] 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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01537094 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Effect of Vitamin C on Growth Hormone Secretion | ||||
| Official Title ICMJE | The Effect of Vitamin C on Growth Hormone Secretion | ||||
| Brief Summary | 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Not yet recruiting | ||||
| Estimated Enrollment ICMJE | 45 | ||||
| Estimated Completion Date | September 2016 | ||||
| Estimated Primary Completion Date | September 2016 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 60 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01537094 | ||||
| Other Study ID Numbers ICMJE | 2011-P-002912 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Hideo Makimura, Massachusetts General Hospital | ||||
| Study Sponsor ICMJE | Massachusetts General Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Massachusetts General Hospital | ||||
| Verification Date | March 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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