Vitamin D DeficiencyNCT00996866
Vitamin D Supplementation Requirement in Obese Subjects
A study testing Vitamin D3 in people with Vitamin D Deficiency, run by Winthrop University Hospital at 1 site in United States.
Trial summary
Vitamin D deficiency is common in obese patients. Most of vitamin D supplementation studies were done with non-obese subjects. This study looks at vitamin D supplementation requirements in obese patients as compared to non-obese subjects. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- Vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Aug 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy men or women between the ages of 18 and 70 years old who are enrolled in our Weight Management Program with baseline BMI > 30 Kg/m2.
Who cannot join
- Pregnancy,
- Serum 25(OH)D level greater than 80 nmol/L,
- Hypercalcemia (serum calcium level greater than the upper limit of normal),
- Recent surgery or illness,
- Those with chronic use of medications that influence calcium/vitamin D metabolism such as anti-convulsants, lithium and steroids. Thiazide diuretics for hypertension will be acceptable.
- Subjects with sarcoidosis will be excluded.
- Those who do not qualify to participate in the Weight Management Program will be excluded. They include subjects with active substance abuse and unstable cardiac disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
Winthrop University Hospital
Mineola, New York, 11501
About this study
Vitamin D deficiency is common in obese patients. Most of vitamin D supplementation studies were done with non-obese subjects. This study looks at vitamin D supplementation requirements in obese patients as compared to non-obese subjects. This study also looks at changes in vitamin D level in obese patients undergoing medical weight loss. It is thought that obese patients have vitamin D deficiency through storage of vitamin D in the fat compartment not readily available for blood measurement. The investigators' hypothesis is that with medical weight loss vitamin D levels will increase in obese subjects.
Read the detailed description
We intend to study changes in serum 25(OH)D level with calorie restricted weight loss in obese subjects. This will be a double dummy, placebo controlled randomized trial. Subjects whose serum 25(OH)D level is below 80 nmol/L will be assigned randomly to either the vitamin D supplemented or the placebo group. Those who are assigned to the placebo group will be weighed on a weekly basis and serum 25(OH)D level will be followed every 8 weeks for a minimum of 16 weeks and extended to the duration of weight loss along with serum calcium level. Changes in serum 25(OH)D level will be obtained with weight loss through restricted caloric intake.
To study the 25(OH)D dose-response curve with vitamin D supplementation in obese subjects, vitamin D supplemented group will receive initial daily vitamin D3 supplementation dose based on their baseline serum 25(OH)D level as described in Methods and Procedures section. Serum 25(OH)D levels will be drawn at 8 weeks and adjustments to the dose will be made based on the an algorithm to achieve serum 25(OH)D levels between 80 and 140 nmol/L. The dose-response curve obtained at 8 weeks will be compared to the one already established with non-obese subjects. Serum 25(OH)D level will be obtained at 16 weeks and compared with the data available from non-obese subjects.
- Conditions
- Vitamin D Deficiency
- Being tested
- Vitamin D3, placebo
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Drug
Vitamin D supplementation will follow an algorithm for initial vitamin D dosing and for dose changes. Subjects will receive 100 ug/day of vitamin D3 if their 25(OH)D level is less than 50nmol/L and 50 ug/day if their 25(OH)D level is between 50 and 80 ug/day.
placeboDrug
The placebo group will receive sugar pills appearing similar to the vitamin D capsules.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Half of subjects will be randomized to the placebo group. Receives: Drug: placebo |
| Vitamin D3 | Active comparator | This is the study group that receives Vitamin D supplementation. Receives: Drug: Vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Level of 25(OH)D
Vitamin D (25(OH)D) level at Baseline.
Measured: Baseline
Mean Level of 25(OH)D
Vitamin D (25(OH)D) level at Month 2.
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2009 (estimated)
- Study startDec 2008
- Primary completionAug 2013
- Study completionAug 2013
Why it stopped: Enable to further recruit study subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Vitamin D DeficiencyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Winthrop University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Aloia,, MD, Principal investigator, Winthrop-Unviersity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00996866
- Sponsor's protocol ID
- 08028
- Status last verified
- Jun 2023
- First submitted
- 15 Oct 2009
- Last updated
- 3 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Supplementation Requirement in Obese Subjects
- ClinicalTrials.gov ID
- NCT00996866
- Acronym / sponsor ID
- 08028
- Conditions
- Vitamin D Deficiency
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enable to further recruit study subjects
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Winthrop University HospitalUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 16 Oct 2009 (estimated)
- Results
- Posted 3 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Vitamin D deficiency is common in obese patients. Most of vitamin D supplementation studies were done with non-obese subjects. This study looks at vitamin D supplementation requirements in obese patients as compared to non-obese subjects. This study also looks at changes in vitamin D level in obese patients undergoing medical weight loss. It is thought that obese patients have vitamin D deficiency through storage of vitamin D in the fat compartment not readily available for blood measurement. The investigators' hypothesis is that with medical weight loss vitamin D levels will increase in obese subjects.
Detailed description
We intend to study changes in serum 25(OH)D level with calorie restricted weight loss in obese subjects. This will be a double dummy, placebo controlled randomized trial. Subjects whose serum 25(OH)D level is below 80 nmol/L will be assigned randomly to either the vitamin D supplemented or the placebo group. Those who are assigned to the placebo group will be weighed on a weekly basis and serum 25(OH)D level will be followed every 8 weeks for a minimum of 16 weeks and extended to the duration of weight loss along with serum calcium level. Changes in serum 25(OH)D level will be obtained with weight loss through restricted caloric intake.
To study the 25(OH)D dose-response curve with vitamin D supplementation in obese subjects, vitamin D supplemented group will receive initial daily vitamin D3 supplementation dose based on their baseline serum 25(OH)D level as described in Methods and Procedures section. Serum 25(OH)D levels will be drawn at 8 weeks and adjustments to the dose will be made based on the an algorithm to achieve serum 25(OH)D levels between 80 and 140 nmol/L. The dose-response curve obtained at 8 weeks will be compared to the one already established with non-obese subjects. Serum 25(OH)D level will be obtained at 16 weeks and compared with the data available from non-obese subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: placeboHalf of subjects will be randomized to the placebo group. |
| Vitamin D3 | Active comparator | Drug: Vitamin D3This is the study group that receives Vitamin D supplementation. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy men or women between the ages of 18 and 70 years old who are enrolled in our Weight Management Program with baseline BMI > 30 Kg/m2.
Key exclusion criteria (7 listed)
- Pregnancy,
- Serum 25(OH)D level greater than 80 nmol/L,
- Hypercalcemia (serum calcium level greater than the upper limit of normal),
- Recent surgery or illness,
- Those with chronic use of medications that influence calcium/vitamin D metabolism such as anti-convulsants, lithium and steroids. Thiazide diuretics for hypertension will be acceptable.
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 D3Vitamin D supplementation will follow an algorithm for initial vitamin D dosing and for dose changes. Subjects will receive 100 ug/day of vitamin D3 if their 25(OH)D level is less than 50nmol/L and 50 ug/day if their 25(OH)D level is between 50 and 80 ug/day. | Drug | Vitamin D3 |
| placeboThe placebo group will receive sugar pills appearing similar to the vitamin D capsules. | Drug | Placebo |
Primary outcome
Mean Level of 25(OH)D
Time frame: Baseline
Vitamin D (25(OH)D) level at Baseline.
Mean Level of 25(OH)D
Time frame: Week 8
Vitamin D (25(OH)D) level at Month 2.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
John Aloia,, MD principal investigator
Winthrop-Unviersity Hospital
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 in people with Vitamin D Deficiency, run by Winthrop University 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 1 inclusion and 7 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: stopped early, as of the sponsor's last update on 3 Jul 2023. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Level of 25(OH)D (time frame: Baseline). The study lists 2 primary outcomes in all. 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 3 Jul 2023.