The Effect of Vitamin C on Growth Hormone Secretion
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ClinicalTrials.gov Identifier: NCT01537094 |
Recruitment Status
:
Withdrawn
(Unable to obtain funding to initiate the study. No subjects were enrolled.)
First Posted
: February 23, 2012
Last Update Posted
: December 13, 2013
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Obese Disorder of Vitamin C Growth Hormone Secretion Abnormality | Dietary Supplement: Placebo Dietary Supplement: Vitamin C 250 mg once daily Dietary Supplement: Vitamin C 1,000 mg once daily | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | The Effect of Vitamin C on Growth Hormone Secretion |
Study Start Date : | December 2013 |
Actual Primary Completion Date : | December 2013 |
Actual Study Completion Date : | December 2013 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Vitamin C low dose
vitamin C 250 mg oral once daily
|
Dietary Supplement: Vitamin C 250 mg once daily |
Active Comparator: Vitamin C high dose
vitamin C 1,000 mg oral once daily
|
Dietary Supplement: Vitamin C 1,000 mg once daily |
Placebo Comparator: Placebo
Placebo oral once daily
|
Dietary Supplement: Placebo |
- Change from Baseline in GH secretion at 4 weeks [ Time Frame: Change from Baseline to 4 weeks ]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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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Men and women age 18-60
- BMI ≥ 30 kg/m2
- Waist circumference ≥ 102 cm in men and ≥ 88 cm in women
- Plasma vitamin C concentration ≤ 23 µmol/l
- Peak stimulated GH ≤ 4.2 µg/l upon GHRH-arginine stimulation test
Exclusion Criteria:
- History of hypopituitarism, pituitary surgery, pituitary/brain radiation, recent traumatic brain injury or any other condition known to affect the GH axis.
- History of severe chronic illness including anemia, chronic kidney disease, liver disease, oxygen dependent COPD or HIV
- Subjects on testosterone, glucocorticoids, anabolic steroids, GHRH, GH or IGF-1 within 3 months of enrollment
- Use of dietary supplements including vitamin C or once daily multi-vitamins
- Subjects with Hgb < 912 g/dL, SGOT > 2.5x upper limit of normal or Creatinine > 1.5 mg/dL
- Subjects with poorly controlled diabetes, defined as HbA1c > 8%.
- Changes in lipid lowering or anti-hypertensive regimen within 3months of screening
- 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
- Any condition judged by the patient's physician to cause this clinical trial to be detrimental to the patient.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01537094
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 |
Principal Investigator: | Hideo Makimura, MD, PhD | Massachusetts General Hospital |
Responsible Party: | Hideo Makimura, Assistant Professor of Medicine, Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT01537094 History of Changes |
Other Study ID Numbers: |
2011-P-002912 |
First Posted: | February 23, 2012 Key Record Dates |
Last Update Posted: | December 13, 2013 |
Last Verified: | December 2013 |
Keywords provided by Hideo Makimura, Massachusetts General Hospital:
low vitamin c reduced growth hormone secretion |
Additional relevant MeSH terms:
Vitamins Ascorbic Acid Hormones Micronutrients Growth Substances |
Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents |