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Hypovitaminosis D : A Link Between Bone/Mineral and Fat/Fuel Metabolism

NCT01315366 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 257

Last updated 2015-11-20

No results posted yet for this study

Summary

The optimal dose of vitamin D needed to optimize beneficial effects on musculoskeletal outcomes remains to be defined. Equally unclear is the impact of vitamin D on fuel metabolism and insulin sensitivity in human subjects. Thus, the overall objective of this proposal is to test the hypothesis that in ambulatory overweight elderly individuals, vitamin D administration at doses higher than currently recommended will:

1. Have a salutary effect on parameters of glucose and fuel metabolism. It will thus decrease indices of insulin resistance, improve lipid profile, and decrease markers of cardiovascular disease including adipokines, inflammatory cytokines, and markers of cell adhesion.
2. Have a superior effect on indices of mineral and musculoskeletal metabolism, including bone remodeling markers, lean mass, and bone mineral density.

We will investigate whether this effect is modulated by entry status of vitaminD and PTH as detailed below

Conditions

Interventions

DIETARY_SUPPLEMENT

Euro D and Ci-CalD

Ci-Cal D (1000mg/day) and vitamin D (500IU/day) daily, plus a supplement of vitamin D3 (20,000 IU/wk) for one year.

DIETARY_SUPPLEMENT

Euro D, Ci-CalD

Ci-Cal D(1000mg/day) and vitamin D (500IU/day) Ci-CalD daily, plus a weekly placebo Euro D supplement for one year.

Sponsors & Collaborators

  • Hotel Dieu de France Hospital

    collaborator OTHER

  • Rafic Hariri University Hospital

    collaborator OTHER

  • American University of Beirut Medical Center

    lead OTHER

Principal Investigators

  • Ghada El Hajj Fuleihan, MD, MPH · American University of Beirut Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2014-08-31
Completion
2015-07-31

Countries

  • Lebanon

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01315366 on ClinicalTrials.gov