Vitamin D Supplementation Requirement in Obese Subjects

NCT00996866 | Terminated Results

• 1 other identifier: 08028
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Vitamin D Deficiency

Outcome Measures

Primary Outcomes (2)

• Mean Level of 25(OH)D

  Vitamin D (25(OH)D) level at Baseline.

  Baseline

• Mean Level of 25(OH)D

  Vitamin D (25(OH)D) level at Month 2.

  Week 8

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Half of subjects will be randomized to the placebo group.

Drug: placebo

Vitamin D3

ACTIVE COMPARATOR

This is the study group that receives Vitamin D supplementation.

Drug: Vitamin D3

Interventions

Vitamin D3 DRUG

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.

Vitamin D3

placebo DRUG

The placebo group will receive sugar pills appearing similar to the vitamin D capsules.

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Winthrop University Hospital: lead

Study Sites (1)

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Results Point of Contact

• Title: John Aloia, MD
• Organization: Winthrop-University Hospital

jaloia@winthrop.org

516-663-2442

Study Officials

• John Aloia,, MD

  Winthrop-Unviersity Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2009
• First Posted: October 16, 2009
• Study Start: December 1, 2008
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: July 3, 2023
• Results First Posted: July 3, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)