Back to resultsVitamin D Supplementation in Obesity and Weight Loss (3DD Study)
Primary Purpose
Osteoporosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
600 IU Vitamin D3
2000 IU Vitamin D3
4000 IU Vitamin D3
Sponsored by
About this trial
This is an interventional health services research trial for Osteoporosis
Eligibility 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.
Sites / Locations
- Rutgers University- Thompson Hall
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
600 IU D3
2000 IU D3
4000 IU D3
Arm Description
Outcomes
Primary Outcome Measures
Bone mineral density (BMD)
BMD
Bone quality
thickness (mm)
Secondary Outcome Measures
Bone turnover markers
osteocalcin (others include PINP and CTX)
Glycemic indices
glucose and insulin
Cognition and biochemical markers
Cognitive measures and serum biochemical markers
cholesterol absorption
Serum levels
serum vitamin D
25(OH)D
Bone regulating hormones
PTH
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01631292
Brief Title
Vitamin D Supplementation in Obesity and Weight Loss (3DD Study)
Official Title
A Pilot Dose Response Study to Vitamin D in Obesity and Weight Loss: Effect on Bone
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
December 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
81 (Actual)
8. Arms, Groups, and Interventions
Arm Title
600 IU D3
Arm Type
Placebo Comparator
Arm Title
2000 IU D3
Arm Type
Active Comparator
Arm Title
4000 IU D3
Arm Type
Active Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
600 IU Vitamin D3
Intervention Description
Once daily
Intervention Type
Dietary Supplement
Intervention Name(s)
2000 IU Vitamin D3
Intervention Description
Once daily
Intervention Type
Dietary Supplement
Intervention Name(s)
4000 IU Vitamin D3
Intervention Description
Once daily
Primary Outcome Measure Information:
Title
Bone mineral density (BMD)
Description
BMD
Time Frame
1 year
Title
Bone quality
Description
thickness (mm)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Bone turnover markers
Description
osteocalcin (others include PINP and CTX)
Time Frame
Baseline, 6mo, 12months
Title
Glycemic indices
Description
glucose and insulin
Time Frame
Baseline, 6 mo and 12 months
Title
Cognition and biochemical markers
Description
Cognitive measures and serum biochemical markers
Time Frame
One year
Title
cholesterol absorption
Description
Serum levels
Time Frame
baseline and one year
Title
serum vitamin D
Description
25(OH)D
Time Frame
Baseline, 6 mo and 12 months
Title
Bone regulating hormones
Description
PTH
Time Frame
Baseline, 6 mo and 12 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
72 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sue Shapses, PhD
Organizational Affiliation
Rutgers University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rutgers University- Thompson Hall
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
30951148
Citation
Castle M, Fiedler N, Pop LC, Schneider SJ, Schlussel Y, Sukumar D, Hao L, Shapses SA. Three Doses of Vitamin D and Cognitive Outcomes in Older Women: A Double-Blind Randomized Controlled Trial. J Gerontol A Biol Sci Med Sci. 2020 Apr 17;75(5):835-842. doi: 10.1093/gerona/glz041.
Results Reference
background
PubMed Identifier
27535752
Citation
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.
Results Reference
background
PubMed Identifier
35538903
Citation
Ogilvie AR, Schlussel Y, Sukumar D, Meng L, Shapses SA. Higher protein intake during caloric restriction improves diet quality and attenuates loss of lean body mass. Obesity (Silver Spring). 2022 Jul;30(7):1411-1419. doi: 10.1002/oby.23428. Epub 2022 May 11.
Results Reference
derived
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Vitamin D Supplementation in Obesity and Weight Loss (3DD Study)
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