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

November 20, 2023 updated by: Sue A. Shapses, Ph.D., RD, Rutgers University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Rutgers University- Thompson Hall

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 72 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone mineral density (BMD)
Time Frame: 1 year
BMD
1 year
Bone quality
Time Frame: 1 year
thickness (mm)
1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rutgers University

Investigators

  • Principal Investigator: Sue Shapses, PhD, Rutgers University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

December 30, 2019

Study Registration Dates

First Submitted

June 30, 2011

First Submitted That Met QC Criteria

June 27, 2012

First Posted (Estimated)

June 29, 2012

Study Record Updates

Last Update Posted (Estimated)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BBGP201095157

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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