Trial to Assess Response to Oral Vitamin D3 Supplementation in Obese Individuals

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-09-30

Brief Summary

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This study is an extension of an earlier study of vitamin D supplementation conducted on normal weight individuals by Dr. John Aloia of the Bone Mineral Research Division at Winthrop University Hospital. The investigators plan to compare the response to vitamin D supplementation in obese individuals with the response already measured in normal weight individuals. The same dosing schedule of vitamin supplementation will be used as in the past. The doses used in the past have demonstrated safety in a number of trials, here at Winthrop as well as outside of Winthrop Hospital. Sixty study volunteers are planned for enrollment in the study. The study participants will mainly be recruited from a group of patients who have in the past been enrolled in the weight loss program at Winthrop Hospital. Each participant will be on vitamin D supplementation for a total of 8 weeks. Vitamin D blood levels will be measured before and at the end of the supplementation period. They will then be compared to see the change over time as a result of supplementation.

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Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Vitamin D

Vitamin D3 supplementation based on baseline 25(OH)D level

Group Type EXPERIMENTAL

Oral vitamin D3

Intervention Type DIETARY_SUPPLEMENT

Vitamin D3 50-100 mcg capsule(depending on baseline serum 25(OH)D concentration) daily for 8 weeks.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo equivalent

Intervention Type DIETARY_SUPPLEMENT

One capsule daily for 8 weeks

Interventions

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Oral vitamin D3

Vitamin D3 50-100 mcg capsule(depending on baseline serum 25(OH)D concentration) daily for 8 weeks.

Intervention Type DIETARY_SUPPLEMENT

Placebo equivalent

One capsule daily for 8 weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* obese adults aged 18-65 years and BMI\>35

Exclusion Criteria

* chronic medical illness (diabetes, malignancy, uncontrolled hypertension, kidney disease)
* subjects who have undergone bariatric surgery or currently enrolled in a medically supervised weight loss program
* BMI \< 35
* pregnancy
* use of medication that influences vitamin D metabolism
* history of of hypercalcemia, hypercalciuria, nephrolithiasis

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes