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

NCT ID: NCT01631292

Last Updated: 2023-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2019-12-30

Brief Summary

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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

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Conditions

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Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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600 IU D3

Group Type PLACEBO_COMPARATOR

600 IU Vitamin D3

Intervention Type DIETARY_SUPPLEMENT

Once daily

2000 IU D3

Group Type ACTIVE_COMPARATOR

2000 IU Vitamin D3

Intervention Type DIETARY_SUPPLEMENT

Once daily

4000 IU D3

Group Type ACTIVE_COMPARATOR

4000 IU Vitamin D3

Intervention Type DIETARY_SUPPLEMENT

Once daily

Interventions

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600 IU Vitamin D3

Once daily

Intervention Type DIETARY_SUPPLEMENT

2000 IU Vitamin D3

Once daily

Intervention Type DIETARY_SUPPLEMENT

4000 IU Vitamin D3

Once daily

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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 Calcium or bone metabolism,
* Evidence of diseases known to influence Calcium metabolism (i.e. metabolic bone disease)
* hyperparathyroidism
* untreated thyroid disease
* significant immune disease
* hepatic disease
* renal disease or a kidney stone in the last 5 years
* significant cardiac disease
* active malignancy or cancer therapy within the past year
Minimum Eligible Age

50 Years

Maximum Eligible Age

72 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Rutgers University

OTHER

Sponsor Role lead

Responsible Party

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Sue A. Shapses, Ph.D., RD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sue Shapses, PhD

Role: PRINCIPAL_INVESTIGATOR

Rutgers University

Locations

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Rutgers University- Thompson Hall

New Brunswick, New Jersey, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 30951148 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27535752 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35538903 (View on PubMed)

Other Identifiers

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BBGP201095157

Identifier Type: -

Identifier Source: org_study_id