Clinical trial NCT02015611: Vitamin D Supplementation and Muscle Function in Older Adults
Official title: Trial of Vitamin D Supplementation and Neuromuscular Function in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuromuscular Function
Keywords: Vitamin D
Muscle power
Muscle fiber
Falls
Aging
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: Office of Dietary Supplements (ODS)
First posted: 2013-12-19
Enrollment: 136
Sex: ALL
Minimum age (years): 65
Maximum age (years): 89
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Lower Extremity Muscle Power Over 12 Months
timeFrame: change from baseline at 12 month follow-up reported
measure: Change in Percentage of Type II (Fast-twitch) Muscle Fibers Over 4 Months
timeFrame: over 4 months of follow-up
Secondary outcomes:
measure: Change in Lower Extremity Muscle Strength Over 12 Months
timeFrame: change from baseline at 12 month follow-up reported
measure: Change in the Short Physical Performance Battery (SPPB) Score Over 12 Months
timeFrame: change from baseline at 12 month follow-up reported
measure: Change in the Expanded Physical Performance Battery Score Over 12 Months
timeFrame: change from baseline at 12 month follow-up reported
measure: Change in Timed Up and Go (TUG) Over 12 Months
timeFrame: change from baseline at 12 month follow-up reported
measure: Change in Average Sway Velocity Over 12 Months
timeFrame: change from baseline at 12 month follow-up reported
measure: Change in 95% Confidence Ellipse Area Over 12 Months
timeFrame: change from baseline at 12 month follow-up reported
measure: Change in Maximum Anteroposterior (AP) Displacement Over 12 Months
timeFrame: change from baseline at 12 month follow-up reported
measure: Change in Maximum Mediolateral (ML) Displacement Over 12 Months
timeFrame: change from baseline at 12 month follow-up reported
Other outcomes:
measure: Number of Falls Over 12 Months
timeFrame: monthly over 12 months
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Denise K Houston, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References: