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

Sponsor

Rutgers University (Other)

Overall Status

Completed

CT.gov ID

NCT01631292

Collaborator

(none)

Enrollment

Location

Arms

119.9

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis	Dietary Supplement: 600 IU Vitamin D3 Dietary Supplement: 2000 IU Vitamin D3 Dietary Supplement: 4000 IU Vitamin D3	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

81 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Health Services Research

Official Title:

A Pilot Dose Response Study to Vitamin D in Obesity and Weight Loss: Effect on Bone

Study Start Date :

Jan 1, 2010

Actual Primary Completion Date :

May 1, 2015

Actual Study Completion Date :

Dec 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 600 IU D3	Dietary Supplement: 600 IU Vitamin D3 Once daily
Active Comparator: 2000 IU D3	Dietary Supplement: 2000 IU Vitamin D3 Once daily
Active Comparator: 4000 IU D3	Dietary Supplement: 4000 IU Vitamin D3 Once daily

Arm

Intervention/Treatment

Placebo Comparator: 600 IU D3

Dietary Supplement: 600 IU Vitamin D3

Once daily

Active Comparator: 2000 IU D3

Dietary Supplement: 2000 IU Vitamin D3

Once daily

Active Comparator: 4000 IU D3

Dietary Supplement: 4000 IU Vitamin D3

Once daily

Outcome Measures

Primary Outcome Measures

Bone mineral density (BMD) [1 year]
BMD
Bone quality [1 year]
thickness (mm)

Secondary Outcome Measures

Bone turnover markers [Baseline, 6mo, 12months]
osteocalcin (others include PINP and CTX)
Glycemic indices [Baseline, 6 mo and 12 months]
glucose and insulin
Cognition and biochemical markers [One year]
Cognitive measures and serum biochemical markers
cholesterol absorption [baseline and one year]
Serum levels
serum vitamin D [Baseline, 6 mo and 12 months]
25(OH)D
Bone regulating hormones [Baseline, 6 mo and 12 months]
PTH

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 72 Years

Sexes Eligible for Study:

Female

Accepts 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 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.