Vitamin D Supplementation in Obesity and Weight Loss (3DD Study)
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ClinicalTrials.gov Identifier: NCT01631292 |
Recruitment Status : Unknown
Verified January 2019 by Sue Shapses, Rutgers University.
Recruitment status was: Active, not recruiting
First Posted : June 29, 2012
Last Update Posted : March 7, 2019
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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 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 |

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 |
- Bone mineral density [ Time Frame: 1 year ]
- 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

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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 |
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.

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
United States, New Jersey | |
Rutgers University- Thompson Hall | |
New Brunswick, New Jersey, United States, 08901 |
Principal Investigator: | Sue Shapses, PhD | Rutgers University |
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 |
Osteoporosis Weight Loss Body Weight 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 |