ObesityNCT00606957
The Effect of Vitamin D Repletion on Insulin Resistance
A study testing Vitamin D3 (cholecalciferol) in people with Obesity, run by Rockefeller University at 1 site in United States.
Trial summary
The reason for doing this study is to learn whether raising a person's vitamin D level from below normal to normal levels will improve his or her body's ability to use sugar. Vitamin D is well known to be an important vitamin for the development and maintenance of bones. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Vitamin D3 (cholecalciferol)
- Type of treatment
- Pill or oral medicine
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to May 2009
- Phase
- Interventional
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Nonsmoking men and women, ages 18-65
- Body mass index (BMI) ≥ 28 kg/m² and within 10% of maximum weight
- Serum 25(OH)D level ≤ 20 ng/ml
- Serum insulin level ≥ 7.2 mU/l
- Willingness to maintain current body weight for the duration of the study
- Willingness to maintain baseline lifestyle activities and routines for the duration of the study
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- Willingness to avoid the use of non-steroidal anti-inflammatory drugs (NSAIDS), including low-dose daily aspirin, for at least ten days prior to each admission (due to the potential effects of these agents on inflammatory markers.)
- Willingness to avoid the use of all over-the-counter or prescription vitamins, dietary supplements, and herbal products during the study, with the exception of a basic multivitamin supplement.
- If of childbearing potential, willingness to use highly effective contraception for the duration of the study.
Who cannot join
- Current tobacco smoking
- History of bleeding or coagulation disorders
- Gastrointestinal disease resulting in significant gastrointestinal dysfunction or malabsorption
- History of diabetes, or diagnosed during screening OGTT
- Current treatment with hypertensive medications
- History of cardiovascular disease
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- Renal disease, as evidenced by a serum creatinine above the upper limit of normal on more than one screening visit
- History of kidney stones
- History of chronic hepatitis, or liver enzymes (AST or ALT) more than 2.5 times the upper limit of normal
- Primary hyperparathyroidism or baseline hypercalcemia from any cause
- Current treatment with over-the-counter or prescription weight loss medications, such as orlistat or sibutramine
- History of bariatric surgery
- Current treatment with any cholesterol-lowering medications, such as statins, niacin, fibrates, or ezetimibe
- Blood pressure ≥ 145/90 after ten minutes of rest on more than one screen visit
- Hyperthyroidism or untreated hypothyroidism. Subjects with chronic, treated, stable hypothyroidism may be included in the study at the discretion of the Principal Investigator.
- Pregnancy, desired pregnancy, or lactation within the study period.
- HIV, Hepatitis B and C
- Medical conditions requiring daily calcium supplementation or antacid use
- Use of medications known to interact with calcium or vitamin D metabolism (bisphosphonates, corticosteroids, thiazide diuretics, cholestyramine, colestipol, mineral oil, phenytoin, barbituates, dititalis glycosides, antacids)
- Subjects with known hypersensitivity to cholecalciferol
- Participation in an investigational drug study within one month of screening
- History, physical, or laboratory findings suggestive of any other medical or psychological condition that would, in the opinion of the principal investigator, make the candidate ineligible for the study
Trial locations and contacts
1 site in 1 country.
About this study
The reason for doing this study is to learn whether raising a person's vitamin D level from below normal to normal levels will improve his or her body's ability to use sugar. Vitamin D is well known to be an important vitamin for the development and maintenance of bones. Recently, scientists have learned that vitamin D may have a role in the prevention of cancer, diabetes, and autoimmune diseases. The investigators are specifically interested in studying this question in the overweight/obese population as they are at greater risk for both vitamin D deficiency and impaired ability to metabolize sugar (glucose intolerance).
Primary Hypotheses:
Read more
Vitamin D repletion (increasing the serum 25(OH)D level from ≤ 20 ng/ml to ≥ 30 ng/ml) will improve insulin sensitivity in individuals who are overweight/obese and insulin resistant.
Secondary Hypotheses:
1.Vitamin D repletion will improve biomarkers of cardiovascular risk and inflammation (directly altering macrophage cytokine production and/or indirectly as a result of improvement in insulin sensitivity.) 2.30,000 IU (0.25 mg) weekly of cholecalciferol (vitamin D3) will raise serum 25(OH)D levels from ≤ 20 ng/ml to ≥ 30 ng/ml overweight/obese population.
- Conditions
- Obesity
- Being tested
- Vitamin D3 (cholecalciferol)
- Keywords
- Obesity, Metabolism
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3 (cholecalciferol)Dietary supplement
Vitamin D will be taken orally, 10,000 IU (0.25 mg) three times per week.
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is change in insulin sensitivity over time, as measured by the glucose clamp, HOMA and OGTT.
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rockefeller University
- Sponsor type
- University, hospital or other
- Investigators
- Allegra Grossman, MD, Principal investigator, The Rockefeller University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00606957
- Sponsor's protocol ID
- RUH IRB# AGR-0623
- Status last verified
- Oct 2011
- First submitted
- 22 Jan 2008
- Last updated
- 13 Oct 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vitamin D Repletion on Insulin Resistance
- ClinicalTrials.gov ID
- NCT00606957
- Acronym / sponsor ID
- RUH IRB# AGR-0623
- Conditions
- Obesity
- Keywords
- Obesity, Metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Rockefeller UniversityUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 5 Feb 2008 (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.
The reason for doing this study is to learn whether raising a person's vitamin D level from below normal to normal levels will improve his or her body's ability to use sugar. Vitamin D is well known to be an important vitamin for the development and maintenance of bones. Recently, scientists have learned that vitamin D may have a role in the prevention of cancer, diabetes, and autoimmune diseases. The investigators are specifically interested in studying this question in the overweight/obese population as they are at greater risk for both vitamin D deficiency and impaired ability to metabolize sugar (glucose intolerance).
Primary Hypotheses:
Vitamin D repletion (increasing the serum 25(OH)D level from ≤ 20 ng/ml to ≥ 30 ng/ml) will improve insulin sensitivity in individuals who are overweight/obese and insulin resistant.
Secondary Hypotheses:
1.Vitamin D repletion will improve biomarkers of cardiovascular risk and inflammation (directly altering macrophage cytokine production and/or indirectly as a result of improvement in insulin sensitivity.) 2.30,000 IU (0.25 mg) weekly of cholecalciferol (vitamin D3) will raise serum 25(OH)D levels from ≤ 20 ng/ml to ≥ 30 ng/ml overweight/obese population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Nonsmoking men and women, ages 18-65
- Body mass index (BMI) ≥ 28 kg/m² and within 10% of maximum weight
- Serum 25(OH)D level ≤ 20 ng/ml
- Serum insulin level ≥ 7.2 mU/l
- Willingness to maintain current body weight for the duration of the study
Key exclusion criteria (22 listed)
- Current tobacco smoking
- History of bleeding or coagulation disorders
- Gastrointestinal disease resulting in significant gastrointestinal dysfunction or malabsorption
- History of diabetes, or diagnosed during screening OGTT
- Current treatment with hypertensive medications
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 |
|---|---|---|
| Vitamin D3 (cholecalciferol)Vitamin D will be taken orally, 10,000 IU (0.25 mg) three times per week. | Dietary supplement | – |
Primary outcome
The primary outcome is change in insulin sensitivity over time, as measured by the glucose clamp, HOMA and OGTT.
Time frame: 14 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2011.
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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.
Allegra Grossman, MD principal investigator
The Rockefeller University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D3 (cholecalciferol) in people with Obesity, run by Rockefeller University 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 9 inclusion and 22 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: finished, as of the sponsor's last update on 13 Oct 2011. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary outcome is change in insulin sensitivity over time, as measured by the glucose clamp, HOMA and OGTT. (time frame: 14 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 Oct 2011.