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
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Vitamin D | 2,000 IU/ day of Vitamin D3 |
| DIETARY_SUPPLEMENT | Placebo | Placebo |
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.