N/A
Completed N=136
Vitamin D Supplementation and Muscle Function in Older Adults
Neuromuscular Function
Source: ClinicalTrials.gov NCT02015611 ↗
Enrolled (actual)
136
Serious AEs
13.2%
Results posted
Nov 2022
Primary outcomePrimary: Change in Lower Extremity Muscle Power Over 12 Months — -0.10; -0.13 Watts/kg — p=0.63
Summary
The purpose of this study is to see if vitamin D supplementation improves muscle function in older adults.
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 |
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
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. Informational only — not medical advice.