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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Osteoporosis Dietary Supplement: 600 IU Vitamin D3 Dietary Supplement: 2000 IU Vitamin D3 Dietary Supplement: 4000 IU Vitamin D3 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : January 2010
Actual Primary Completion Date : May 2015
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Bone mineral density [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Bone turnover markers [ Time Frame: Baseline, 3 mo, 6mo, 12months ]
    Serum and urinary calcium are measured as safety markers

  2. Glycemic indices and insulin resistance [ Time Frame: Baseline, 6 mo and 12 months ]
  3. Cognition and biochemical markers [ Time Frame: One year ]
    Cognitive measures and serum biochemical markers

  4. Lipid markers and cholesterol absorption [ Time Frame: one year ]
    Serum levels


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 72 Years   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01631292


Locations
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United States, New Jersey
Rutgers University- Thompson Hall
New Brunswick, New Jersey, United States, 08901
Sponsors and Collaborators
Rutgers University
Investigators
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Principal Investigator: Sue Shapses, PhD Rutgers University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sue Shapses, Professor, Rutgers University
ClinicalTrials.gov Identifier: NCT01631292    
Other Study ID Numbers: BBGP201095157
First Posted: June 29, 2012    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
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Osteoporosis
Weight Loss
Body Weight
Signs and Symptoms
Body Weight Changes
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Vitamin D
 Ergocalciferols
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents