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

Not Applicable

Completed

• Conditions: Osteoporosis
• Interventions: Dietary Supplement: 600 IU Vitamin D3; Dietary Supplement: 4000 IU Vitamin D3; Dietary Supplement: 2000 IU Vitamin D3

• 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

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2011-06-30
• Study First Submitted QC: 2012-06-27
• Study First Posted: 2012-06-29
• Primary Completion: 2015-05
• Study Completion: 2019-12-30
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-20
• Last Update Posted: 2023-11-22

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

Arm && Interventions

Group	Intervention	Description
600 IU D3	600 IU Vitamin D3	-
4000 IU D3	4000 IU Vitamin D3	-
2000 IU D3	2000 IU Vitamin D3	-

Primary Outcome Measures

Name	Time	Method
Bone mineral density (BMD)	1 year	BMD
Bone quality	1 year	thickness (mm)

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