N/A N=136 Randomized Double-blind Prevention

Vitamin D Supplementation and Muscle Function in Older Adults

Neuromuscular Function

Bottom Line

View on ClinicalTrials.gov: NCT02015611 ↗

Enrolled (actual)

136

Serious AEs

13.2%

Results posted

Nov 2022

Primary outcome: Primary: Change in Lower Extremity Muscle Power Over 12 Months — -0.10; -0.13 Watts/kg — p=0.63

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Vitamin D (Dietary_supplement); Placebo (Dietary_supplement)
Age: Older Adult · 65+ yrs
Sex: All
Sponsor: Wake Forest University Health Sciences
Primary completion: Sep 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Lower Extremity Muscle Power Over 12 Months	-0.10; -0.13	0.63
PRIMARY Change in Percentage of Type II (Fast-twitch) Muscle Fibers Over 4 Months	-1.35; -3.68	0.64
SECONDARY Change in Lower Extremity Muscle Strength Over 12 Months	-3.84; -8.09	0.08
SECONDARY Change in the Short Physical Performance Battery (SPPB) Score Over 12 Months	1.83; 1.64	0.53
SECONDARY Change in the Expanded Physical Performance Battery Score Over 12 Months	0.17; 0.19	0.75
SECONDARY Change in Timed Up and Go (TUG) Over 12 Months	0.98; 1.01	0.92
SECONDARY Change in Average Sway Velocity Over 12 Months	0.01; 0.01	0.94
SECONDARY Change in 95% Confidence Ellipse Area Over 12 Months	0.00; 0.03	0.61
SECONDARY Change in Maximum Anteroposterior (AP) Displacement Over 12 Months	0.00; 0.02	0.59
SECONDARY Change in Maximum Mediolateral (ML) Displacement Over 12 Months	-0.01; 0.06	0.21

Summary

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

Eligibility Criteria

Inclusion Criteria

Age ≥65 to 200/110 mmHg); chronic respiratory disease requiring the use of oxygen; uncontrolled endocrine/metabolic disease; neurological (e.g., Parkinson's disease) or hematological disease; liver or renal dysfunction (eGFR 1000 IU/day of vitamin D3 (from all sources); taking an oral corticosteroid (i.e., prednisone at 7.5mg/d for 3 mos or equivalent); taking hormone replacement therapy
Inability or contraindications to consume daily vitamin D supplements (e.g., hypercalcemia, sarcoidosis, history of kidney stones in last 5 years)
Knee or hip surgery within the last 6 months or planned knee or hip surgery within the next year
Unwillingness to undergo a muscle biopsy or use of anti-coagulants
Unintentional weight loss of ≥5% or more in the past 3 months
BMI >40 kg/m2
If the PI feels the participant is unlikely to follow the protocol

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02015611). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.