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The Effect of Vitamin C on Growth Hormone Secretion

Primary Purpose

Obese, Disorder of Vitamin C, Growth Hormone Secretion Abnormality

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Placebo
Vitamin C 250 mg once daily
Vitamin C 1,000 mg once daily
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obese focused on measuring low vitamin c, reduced growth hormone secretion

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Men and women age 18-60
  2. BMI ≥ 30 kg/m2
  3. Waist circumference ≥ 102 cm in men and ≥ 88 cm in women
  4. Plasma vitamin C concentration ≤ 23 µmol/l
  5. Peak stimulated GH ≤ 4.2 µg/l upon GHRH-arginine stimulation test

Exclusion Criteria:

  1. History of hypopituitarism, pituitary surgery, pituitary/brain radiation, recent traumatic brain injury or any other condition known to affect the GH axis.
  2. History of severe chronic illness including anemia, chronic kidney disease, liver disease, oxygen dependent COPD or HIV
  3. Subjects on testosterone, glucocorticoids, anabolic steroids, GHRH, GH or IGF-1 within 3 months of enrollment
  4. Use of dietary supplements including vitamin C or once daily multi-vitamins
  5. Subjects with Hgb < 912 g/dL, SGOT > 2.5x upper limit of normal or Creatinine > 1.5 mg/dL
  6. Subjects with poorly controlled diabetes, defined as HbA1c > 8%.
  7. Changes in lipid lowering or anti-hypertensive regimen within 3months of screening
  8. 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
  9. Any condition judged by the patient's physician to cause this clinical trial to be detrimental to the patient.

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Vitamin C low dose

Vitamin C high dose

Placebo

Arm Description

vitamin C 250 mg oral once daily

vitamin C 1,000 mg oral once daily

Placebo oral once daily

Outcomes

Primary Outcome Measures

Change from Baseline in GH secretion at 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.

Secondary Outcome Measures

Full Information

First Posted
February 10, 2012
Last Updated
December 11, 2013
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01537094
Brief Title
The Effect of Vitamin C on Growth Hormone Secretion
Official Title
The Effect of Vitamin C on Growth Hormone Secretion
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Withdrawn
Why Stopped
Unable to obtain funding to initiate the study. No subjects were enrolled.
Study Start Date
December 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obese, Disorder of Vitamin C, Growth Hormone Secretion Abnormality
Keywords
low vitamin c, reduced growth hormone secretion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitamin C low dose
Arm Type
Active Comparator
Arm Description
vitamin C 250 mg oral once daily
Arm Title
Vitamin C high dose
Arm Type
Active Comparator
Arm Description
vitamin C 1,000 mg oral once daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo oral once daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin C 250 mg once daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin C 1,000 mg once daily
Primary Outcome Measure Information:
Title
Change from Baseline in GH secretion at 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.
Time Frame
Change from Baseline to 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hideo Makimura, MD, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

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The Effect of Vitamin C on Growth Hormone Secretion

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