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

June 30, 2011
July 12, 2014
January 2010
May 2015   (final data collection date for primary outcome measure)
Bone mineral density [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01631292 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Vitamin D Supplementation in Obesity and Weight Loss (3DD Study)
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Osteoporosis
  • Dietary Supplement: 600 IU Vitamin D3
    Once daily
  • Dietary Supplement: 2000 IU Vitamin D3
    Once daily
  • Dietary Supplement: 4000 IU Vitamin D3
    Once daily
  • Placebo Comparator: 600 IU D3
    Intervention: Dietary Supplement: 600 IU Vitamin D3
  • Active Comparator: 2000 IU D3
    Intervention: Dietary Supplement: 2000 IU Vitamin D3
  • Active Comparator: 4000 IU D3
    Intervention: Dietary Supplement: 4000 IU Vitamin D3
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
48
December 2015
May 2015   (final data collection date for primary outcome measure)

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.
Female
50 Years to 72 Years
Yes
Contact: Claudia Pop, MD 732 932 9734 RUwtloss@gmail.com
Contact: Robert Zurfluh, RD 732 932 9734 RUwtloss@gmail.com
United States
 
NCT01631292
BBGP201095157
No
Sue Shapses, Rutgers University
Rutgers University
Not Provided
Principal Investigator: Sue Shapses, PhD Rutgers University
Rutgers University
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP