Osteoporosis
Conditions
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.
Interventions
DIETARY_SUPPLEMENT600 IU Vitamin D3
Once daily
DIETARY_SUPPLEMENT2000 IU Vitamin D3
Once daily
DIETARY_SUPPLEMENT4000 IU Vitamin D3
Once daily
Sponsors
Rutgers University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 72 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bone mineral density (BMD) | 1 year | BMD |
| Bone quality | 1 year | thickness (mm) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cognition and biochemical markers | One year | Cognitive measures and serum biochemical markers |
| cholesterol absorption | baseline and one year | Serum levels |
| Bone turnover markers | Baseline, 6 months, 12 months | osteocalcin (others include PINP and CTX) |
| Bone regulating hormones | Baseline, 6 months and 12 months | PTH |
| serum vitamin D | Baseline, 6 months and 12 months | 25(OH)D |
| Glycemic indices | Baseline, 6 months and 12 months | glucose and insulin |
Countries
United States
Outcome results
None listed