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Completed

NCT Number: NCT00960037

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

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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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Winthrop University Hospital

Mineola, New York, 11501, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral vitamin D3

Dietary Supplement

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

Placebo equivalent

Dietary Supplement

One capsule daily for 8 weeks

Primary outcomes

  1. Change in serum 25(OH)D level from baseline.

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Winthrop University Hospital

Other

Registry information

Official study title

The Vitamin D Dose Response Curve in Obesity

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Aug 17, 2009
Registry last updated
Jun 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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