ObesePhase 2NCT01537094
The Effect of Vitamin C on Growth Hormone Secretion
A Phase 2 study testing Vitamin C 250 mg once daily and Vitamin C 1,000 mg once daily in people with Obese and Disorder of Vitamin C, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obese, Disorder of Vitamin C, Growth Hormone Secretion Abnormality
- What is being tested?
- Vitamin C 250 mg once daily and Vitamin C 1,000 mg once daily
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Dec 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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%.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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.
- Being tested
- Placebo, Vitamin C 250 mg once daily, Vitamin C 1,000 mg once daily
- Keywords
- low vitamin c, reduced growth hormone secretion
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Vitamin C 250 mg once dailyDietary supplement
Vitamin C 1,000 mg once dailyDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Vitamin C low dose | Active comparator | vitamin C 250 mg oral once daily Receives: Dietary Supplement: Vitamin C 250 mg once daily |
| Vitamin C high dose | Active comparator | vitamin C 1,000 mg oral once daily Receives: Dietary Supplement: Vitamin C 1,000 mg once daily |
| Placebo | Placebo comparator | Placebo oral once daily Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2012 (estimated)
- Study startDec 2013
- Primary completionDec 2013
- Study completionDec 2013
Why it stopped: Unable to obtain funding to initiate the study. No subjects were enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObeseStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hideo Makimura, Massachusetts General Hospital
- Investigators
- Hideo Makimura, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01537094
- Sponsor's protocol ID
- 2011-P-002912
- Status last verified
- Dec 2013
- First submitted
- 10 Feb 2012
- Last updated
- 13 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vitamin C on Growth Hormone Secretion
- ClinicalTrials.gov ID
- NCT01537094
- Acronym / sponsor ID
- 2011-P-002912
- Keywords
- low vitamin c, reduced growth hormone secretion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to obtain funding to initiate the study. No subjects were enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 23 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vitamin C low dose | Active comparator | Dietary Supplement: Vitamin C 250 mg once dailyvitamin C 250 mg oral once daily |
| Vitamin C high dose | Active comparator | Dietary Supplement: Vitamin C 1,000 mg once dailyvitamin C 1,000 mg oral once daily |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo oral once daily |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo | Dietary supplement | Placebo |
| Vitamin C 250 mg once daily | Dietary supplement | Vitamin C low dose |
| Vitamin C 1,000 mg once daily | Dietary supplement | Vitamin C high dose |
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hideo Makimura, MD, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vitamin C 250 mg once daily and Vitamin C 1,000 mg once daily in people with Obese and Disorder of Vitamin C, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in GH secretion at 4 weeks (time frame: Change from Baseline to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2013.