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A Pilot Study to Examine the Effects of Vitamin D Supplementation on Mitochondrial Bioenergetics in Older Adults

NCT02445066 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2018-08-15

No results posted yet for this study

Summary

This pilot study is a 4-month open label trial in 15 older (65-89 yrs) men and women with initial 25(OH)D concentrations of 12-\<18 ng/mL to explore the effect of increasing 25(OH)D concentrations to ≥30 ng/mL through vitamin D3 supplementation on changes in mitochondrial bioenergetics. We will assess the bioenergetic profile of blood cells isolated mitochondria, and muscle fibers as well as the expression of mitochondrial proteins and regulators of mitochondria biogenesis before and after supplementation. All participants will be given vitamin D3 (4,000 IU/d) for 4 months.

Conditions

  • Low 25-hydroxyvitamin D Concentrations

Interventions

DIETARY_SUPPLEMENT

Vitamin D3

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Anthony Molina, PhD · Wake Forest University Health Sciences

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
65 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2017-08-31
Completion
2017-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT02445066 on ClinicalTrials.gov