Vitamin D Supplementation in Obesity and Weight Loss (3DD Study)
Not Applicable
Completed
- Conditions
- Osteoporosis
- Registration Number
- NCT01631292
- Lead Sponsor
- Rutgers University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 81
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 Calcium or bone metabolism,
- Evidence of diseases known to influence Calcium metabolism (i.e. metabolic bone disease)
- hyperparathyroidism
- untreated thyroid disease
- significant immune disease
- hepatic disease
- renal disease or a kidney stone in the last 5 years
- significant cardiac disease
- active malignancy or cancer therapy within the past year
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Bone quality 1 year thickness (mm)
Bone mineral density (BMD) 1 year BMD
- Secondary Outcome Measures
Name Time Method cholesterol absorption baseline and one year Serum levels
Cognition and biochemical markers One year Cognitive measures and serum biochemical markers
serum vitamin D Baseline, 6 months and 12 months 25(OH)D
Bone turnover markers Baseline, 6 months, 12 months osteocalcin (others include PINP and CTX)
Glycemic indices Baseline, 6 months and 12 months glucose and insulin
Bone regulating hormones Baseline, 6 months and 12 months PTH
Trial Locations
- Locations (1)
Rutgers University- Thompson Hall
🇺🇸New Brunswick, New Jersey, United States
Rutgers University- Thompson Hall🇺🇸New Brunswick, New Jersey, United States