Vitamin D Supplementation in Obesity and Weight Loss (3DD Study)

Rutgers The State University of New Jersey

Status: Completed

Conditions: Osteoporosis

Treatments: Dietary Supplement: 600 IU Vitamin D3; Dietary Supplement: 4000 IU Vitamin D3; Dietary Supplement: 2000 IU Vitamin D3

Study type: Interventional

Funder types: Other

Identifiers

NCT01631292

BBGP201095157

Details and patient eligibility

About

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.

Enrollment: 81 patients

Sex: Female

Ages: 50 to 72 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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81 participants in 3 patient groups, including a placebo group

600 IU D3

Placebo Comparator group

Treatment:

Dietary Supplement: 600 IU Vitamin D3

2000 IU D3

Active Comparator group

Treatment:

Dietary Supplement: 2000 IU Vitamin D3

4000 IU D3

Active Comparator group

Treatment:

Dietary Supplement: 4000 IU Vitamin D3