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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01631292
Recruitment Status : Active, not recruiting
First Posted : June 29, 2012
Last Update Posted : March 7, 2019
Sponsor:
Information provided by (Responsible Party):
Sue Shapses, Rutgers University

Tracking Information
First Submitted Date  ICMJE June 30, 2011
First Posted Date  ICMJE June 29, 2012
Last Update Posted Date March 7, 2019
Study Start Date  ICMJE January 2010
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 27, 2012)
Bone mineral density [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2019)
  • 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 serum biochemical markers
  • Lipid markers and cholesterol absorption [ Time Frame: one year ]
    Serum levels
Original Secondary Outcome Measures  ICMJE
 (submitted: June 27, 2012)
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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vitamin D Supplementation in Obesity and Weight Loss (3DD Study)
Official Title  ICMJE A Pilot Dose Response Study to Vitamin D in Obesity and Weight Loss: Effect on Bone
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Condition  ICMJE Osteoporosis
Intervention  ICMJE
  • Dietary Supplement: 600 IU Vitamin D3
    Once daily
  • Dietary Supplement: 2000 IU Vitamin D3
    Once daily
  • Dietary Supplement: 4000 IU Vitamin D3
    Once daily
Study Arms  ICMJE
  • 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
Publications * Pop LC, Sukumar D, Schneider SH, Schlussel Y, Stahl T, Gordon C, Wang X, Papathomas TV, Shapses SA. Three doses of vitamin D, bone mineral density, and geometry in older women during modest weight control in a 1-year randomized controlled trial. Osteoporos Int. 2017 Jan;28(1):377-388. doi: 10.1007/s00198-016-3735-z. Epub 2016 Aug 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 14, 2016)
81
Original Estimated Enrollment  ICMJE
 (submitted: June 27, 2012)
48
Estimated Study Completion Date  ICMJE December 2019
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 50 Years to 72 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01631292
Other Study ID Numbers  ICMJE BBGP201095157
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sue Shapses, Rutgers University
Study Sponsor  ICMJE Rutgers University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sue Shapses, PhD Rutgers University
PRS Account Rutgers University
Verification Date January 2019

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