Clinical Trials Directory

Trials / Completed

CompletedNCT02015611

Vitamin D Supplementation and Muscle Function in Older Adults

Trial of Vitamin D Supplementation and Neuromuscular Function in Older Adults

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
136 (actual)
Sponsor
Wake Forest University Health Sciences · Academic / Other
Sex
All
Age
65 Years – 89 Years
Healthy volunteers
Accepted

Summary

The purpose of this study is to see if vitamin D supplementation improves muscle function in older adults.

Detailed description

This study is a 12-month, double-blind randomized placebo controlled trial in older (65-89 yrs) men and women with initial 25(OH)D concentrations of 18-\<30 ng/mL to determine the effect of increasing 25(OH)D concentrations to ≥30 ng/mL through vitamin D3 supplementation on 1) change in neuromuscular functions that are established risk-factors for falls in older adults; and 2) changes in the underlying physiological mechanisms over 4 months in a subset of randomly selected participants. Participants will be randomized to 2000 IU/d of vitamin D3 or placebo. Lower extremity muscle strength and power, physical performance, and postural sway will be assessed at baseline, 4 months and 12 months and falls assessed monthly. Muscle biopsies of the vastus lateralis will be taken at baseline and 4 months to assess muscle fiber type, contractility, and denervation, and number and differentiation stage of satellite cells.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTVitamin D2,000 IU/ day of Vitamin D3
DIETARY_SUPPLEMENTPlaceboPlacebo

Timeline

Start date
2013-12-01
Primary completion
2018-09-26
Completion
2018-09-26
First posted
2013-12-19
Last updated
2022-11-15
Results posted
2022-11-15

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02015611. Inclusion in this directory is not an endorsement.