The Effect of Vitamin C on Growth Hormone Secretion | NCT01537094

Studies
The Effect of Vitamin C on Growth Hormone Secretion

NCT01537094

Sponsor

Massachusetts General Hospital

Status

Withdrawn

Last Update Posted

Dec 13, 2013Estimated

Enrollment

0Actual

Phase

Phase 2

Conditions

Obese
Disorder of Vitamin C
Growth Hormone Secretion Abnormality

Interventions

Placebo
Vitamin C 250 mg once daily
Vitamin C 1,000 mg once daily

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2013

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Unable to obtain funding to initiate the study. No subjects were enrolled.

Expanded Access Info

Start Date

Dec 2013

Primary Completion Date

Dec 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Feb 10, 2012

First Submission Date that Met QC Criteria

Feb 16, 2012

First Posted Date

Feb 23, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 11, 2013

Last Update Posted Date

Dec 13, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vitamin C low dose	Active Comparator	vitamin C 250 mg oral once daily	Dietary Supplement: Vitamin C 250 mg once daily
Vitamin C high dose	Active Comparator	vitamin C 1,000 mg oral once daily	Dietary Supplement: Vitamin C 1,000 mg once daily
Placebo	Placebo Comparator	Placebo oral once daily	Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Dietary Supplement		Placebo
Vitamin C 250 mg once daily

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	Change from Baseline to 4 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

ID	Term
D013400	Sugar Acids
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals