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

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ClinicalTrials.gov Identifier: NCT01631292
Recruitment Status : Active, not recruiting
First Posted : June 29, 2012
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
Sue Shapses, Rutgers University

June 30, 2011
June 29, 2012
January 17, 2018
January 2010
May 2015   (Final data collection date for primary outcome measure)
Bone mineral density [ Time Frame: 1 year ]
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 ]
    Serum and urinary calcium are measured as safety markers
  • Glycemic indices and insulin resistance [ Time Frame: Baseline, 6 mo and 12 months ]
  • Cognition and biochemical markers [ Time Frame: One year ]
    Cognitive measures and biochemical markers
Bone turnover markers [ Time Frame: Baseline, 3 mo, 6mo, 12months ]
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
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: Quadruple (Participant, Care Provider, 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.
 
Active, not recruiting
81
December 2018
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.
Sexes Eligible for Study: Female
50 Years to 72 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01631292
BBGP201095157
No
Not Provided
Not Provided
Sue Shapses, Rutgers University
Rutgers University
Not Provided
Principal Investigator: Sue Shapses, PhD Rutgers University
Rutgers University
January 2018

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