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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2012 by Rutgers University
Sponsor:
Information provided by (Responsible Party):
Sue Shapses, Rutgers University
ClinicalTrials.gov Identifier:
NCT01631292
First received: June 30, 2011
Last updated: July 12, 2014
Last verified: June 2012
  Purpose

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 Intervention
Osteoporosis
Dietary Supplement: 600 IU Vitamin D3
Dietary Supplement: 2000 IU Vitamin D3
Dietary Supplement: 4000 IU Vitamin D3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Rutgers University:

Primary Outcome Measures:
  • Bone mineral density [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bone turnover markers [ Time Frame: Baseline, 3 mo, 6mo, 12months ] [ Designated as safety issue: No ]
    Other key measures that will be used to evaluate the intervention include tests of insulin resistance and cognition Serum and urinary calcium are measured as safety markers


Estimated Enrollment: 48
Study Start Date: January 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years to 72 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01631292

Contacts
Contact: Claudia Pop, MD 732 932 9734 RUwtloss@gmail.com
Contact: Robert Zurfluh, RD 732 932 9734 RUwtloss@gmail.com

Locations
United States, New Jersey
Rutgers University- Thompson Hall Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Sue Shapses, PhD    732-932-9403      
Principal Investigator: Sue Shapses, PhD         
Sponsors and Collaborators
Rutgers University
Investigators
Principal Investigator: Sue Shapses, PhD Rutgers University
  More Information

No publications provided

Responsible Party: Sue Shapses, Professor, Rutgers University
ClinicalTrials.gov Identifier: NCT01631292     History of Changes
Other Study ID Numbers: BBGP201095157
Study First Received: June 30, 2011
Last Updated: July 12, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Osteoporosis
Weight Loss
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Body Weight Changes
Body Weight
Signs and Symptoms
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 16, 2014