Vitamin D Supplementation and Muscle Function in Older Adults

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2018-09-26

Brief Summary

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

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Detailed Description

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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

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Neuromuscular Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Placebo

Matched bottle/pill placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo

Vitamin D

2,000 IU Vitamin D3 per day

Group Type EXPERIMENTAL

Vitamin D

Intervention Type DIETARY_SUPPLEMENT

2,000 IU/ day of Vitamin D3

Interventions

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Vitamin D

2,000 IU/ day of Vitamin D3

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

65 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes