This trial is active, not recruiting.

Condition osteoporosis
Treatments 600 iu vitamin d3, 2000 iu vitamin d3, 4000 iu vitamin d3
Sponsor Rutgers University
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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose health services research
(Placebo Comparator)
600 iu vitamin d3
Once daily
(Active Comparator)
2000 iu vitamin d3
Once daily
(Active Comparator)
4000 iu vitamin d3
Once daily

Primary Outcomes

Bone mineral density
time frame: 1 year

Secondary Outcomes

Bone turnover markers
time frame: Baseline, 3 mo, 6mo, 12months

Eligibility Criteria

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.

Additional Information

Official title A Pilot Dose Response Study to Vitamin D in Obesity and Weight Loss: Effect on Bone
Principal investigator Sue Shapses, PhD
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Rutgers University.