NCT01631292

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 30, 2011

Completed
1 year until next milestone

First Posted

Study publicly available on registry

June 29, 2012

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
4.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
Last Updated

November 22, 2023

Status Verified

November 1, 2023

Enrollment Period

5.3 years

First QC Date

June 30, 2011

Last Update Submit

November 20, 2023

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (2)

  • Bone mineral density (BMD)

    BMD

    1 year

  • Bone quality

    thickness (mm)

    1 year

Secondary Outcomes (6)

  • Bone turnover markers

    Baseline, 6 months, 12 months

  • Glycemic indices

    Baseline, 6 months and 12 months

  • Cognition and biochemical markers

    One year

  • cholesterol absorption

    baseline and one year

  • serum vitamin D

    Baseline, 6 months and 12 months

  • +1 more secondary outcomes

Study Arms (3)

600 IU D3

PLACEBO COMPARATOR
Dietary Supplement: 600 IU Vitamin D3

2000 IU D3

ACTIVE COMPARATOR
Dietary Supplement: 2000 IU Vitamin D3

4000 IU D3

ACTIVE COMPARATOR
Dietary Supplement: 4000 IU Vitamin D3

Interventions

600 IU Vitamin D3DIETARY_SUPPLEMENT

Once daily

600 IU D3
2000 IU Vitamin D3DIETARY_SUPPLEMENT

Once daily

2000 IU D3
4000 IU Vitamin D3DIETARY_SUPPLEMENT

Once daily

4000 IU D3

Eligibility Criteria

Age50 Years - 72 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Body mass index of 25-40 kg/m2
  • Postmenopausal
  • Age 50-72 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rutgers University- Thompson Hall

New Brunswick, New Jersey, 08901, United States

Location

Related Publications (3)

  • 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.

    PMID: 30951148BACKGROUND

  • 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.

    PMID: 27535752BACKGROUND

  • 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.

    PMID: 35538903DERIVED

MeSH Terms

Conditions

Osteoporosis

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Sue Shapses, PhD

    Rutgers University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 30, 2011

First Posted

June 29, 2012

Study Start

January 1, 2010

Primary Completion

May 1, 2015

Study Completion

December 30, 2019

Last Updated

November 22, 2023

Record last verified: 2023-11

Locations

US(1)