Vitamin D Supplementation Requirement in Obese Subjects

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Winthrop University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Winthrop University Hospital
ClinicalTrials.gov Identifier:
NCT00996866
First received: October 15, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Vitamin D Deficiency
Drug: Vitamin D3
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Vitamin D Supplementation Requirement in Obese Subjects

Resource links provided by NLM:


Further study details as provided by Winthrop University Hospital:

Primary Outcome Measures:
  • Mean level of 25(OH)D during calorie restricted weight loss from the placebo group. [ Time Frame: baseline and at 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Dose response curve (the 'slope' i.e. the ratio of ∆ 25(OH)D/ initial vitamin D3 dose) in vitamin D supplemented group. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: December 2008
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Half of subjects will be randomized to the placebo group.
Drug: placebo
The placebo group will receive sugar pills appearing similar to the vitamin D capsules.
Active Comparator: Vitamin D3
This is the study group that receives Vitamin D supplementation.
Drug: Vitamin D3
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00996866

Contacts
Contact: Namyi Yu, MD 516 663-9529 nyu@winthrop.org

Locations
United States, New York
Winthrop University Hospital Recruiting
Mineola, New York, United States, 11501
Contact: Jane Greensher, RN    516-663-4776    jmoore@winthrop.org   
Sponsors and Collaborators
Winthrop University Hospital
  More Information

No publications provided

Responsible Party: Namyi Yu, MD, Winthrop-University Hospital
ClinicalTrials.gov Identifier: NCT00996866     History of Changes
Other Study ID Numbers: 08028
Study First Received: October 15, 2009
Last Updated: October 15, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 28, 2014