Vitamin D Supplementation in Obesity and Weight Loss (3DD Study)
This trial is active, not recruiting.
|Treatments||600 iu vitamin d3, 2000 iu vitamin d3, 4000 iu vitamin d3|
|Start date||January 2010|
|End date||May 2015|
|Trial size||81 participants|
|Trial identifier||NCT01631292, BBGP201095157|
In this study, we will provide supplemental vitamin D in postmenopausal overweight/obese women, and hypothesize that it will not affect areal BMD, but will alter bone compartments (trabecular and cortical bone). In addition, higher vitamin D intake will increase serum 25OHD and suppress serum PTH and bone turnover during weight reduction. Secondary outcomes include the influence of vitamin D and weight loss on markers of insulin resistance and on cognitive tests of attention, learning, and memory.
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
|Primary purpose||health services research|
Bone mineral density
time frame: 1 year
Bone turnover markers
time frame: Baseline, 3 mo, 6mo, 12months
Female participants from 50 years up to 72 years old.
Inclusion Criteria: - Body mass index of 25-40 kg/m2, - Postmenopausal, - Age 50-72 years. Exclusion Criteria: - Women who are taking any medication known to influence Ca or bone metabolism, or with evidence of diseases known to influence Ca metabolism (i.e. metabolic bone disease, hyperparathyroidism, untreated thyroid disease, significant immune, hepatic, or renal disease, a kidney stone in the last 5 yrs., significant cardiac disease, active malignancy or cancer therapy within the past year) are not eligible.
|Official title||A Pilot Dose Response Study to Vitamin D in Obesity and Weight Loss: Effect on Bone|
|Principal investigator||Sue Shapses, PhD|
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