Vitamin D Supplementation and Muscle Function in Older Adults (EVIDENCE)

Wake Forest University (WFU)

Status

Completed

Conditions

Neuromuscular Function

Treatments

Dietary Supplement: Placebo

Dietary Supplement: Vitamin D

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT02015611

IRB00022395

R01AG042411 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment

136 patients

Sex

All

Ages

65 to 89 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Age ≥65 to <90 years
SPPB <=10
Initial serum 25(OH)D concentration of 18 to <30 ng/mL
Not dependent on a walker
Able to provide own transportation to study visits
Not involved in another intervention study
Willing to provide informed consent and adhere to the protocol

Exclusion criteria

Serious or uncontrolled chronic disease including: insulin-dependent diabetes; cancer requiring treatment in past year, except non-melanoma skin cancers; acute coronary event (within the last 6 months), uncontrolled angina, heart failure (stage 3-4), PAD, or stroke (within the last 6 months); uncontrolled hypertension (BP>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 <45 mL/min/1.73m2); and musculoskeletal impairments severe enough to preclude functional testing
Evidence of impaired cognitive function (MoCA <18)
Taking prescription vitamin D2 or taking >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