Vitamin D Supplementation and Muscle Function in Older Adults

NCT02015611 | Completed Results DMC

• 2 other identifiers: IRB00022395R01AG042411
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Neuromuscular Function

Keywords

Vitamin D; Muscle power; Muscle fiber; Falls; Aging

Outcome Measures

Primary Outcomes (2)

• Change in Lower Extremity Muscle Power Over 12 Months

  Lower extremity muscle power will be measured at baseline, 4- and 12-month follow-up using the Nottingham Power Rig. Participants sit in a chair and unilaterally depress a foot lever attached to a flywheel as hard and as fast as they can. Power output, derived from the acceleration of the flywheel from 5 trials on each leg at maximal effort, will be recorded in Watts. Maximum leg power at baseline (from either the right or left leg) and the maximum power from the same leg at 4- and 12-month follow-up will be used in all analyses. Leg power (Watts) will be standardized to total body mass (in Kg).

  change from baseline at 12 month follow-up reported

• Change in Percentage of Type II (Fast-twitch) Muscle Fibers Over 4 Months

  This will be examined in muscle biopsies collected at baseline and 4-month follow-up using the ATPase, pH 9.4 technique, combined with laminin immunostaining in 10 micrometer muscle sections and the number of type I and type II fiber subtypes quantified. The percentage of type II fibers is calculated by dividing the number of type II fibers by the sum of type I and type II fibers combined.

  over 4 months of follow-up

Secondary Outcomes (8)

• Change in Lower Extremity Muscle Strength Over 12 Months

  change from baseline at 12 month follow-up reported

• Change in the Short Physical Performance Battery (SPPB) Score Over 12 Months

  change from baseline at 12 month follow-up reported

• Change in the Expanded Physical Performance Battery Score Over 12 Months

  change from baseline at 12 month follow-up reported

• Change in Timed Up and Go (TUG) Over 12 Months

  change from baseline at 12 month follow-up reported

• Change in Average Sway Velocity Over 12 Months

  change from baseline at 12 month follow-up reported

Other Outcomes (1)

• Number of Falls Over 12 Months

  monthly over 12 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Matched bottle/pill placebo

Dietary Supplement: Placebo

Vitamin D

EXPERIMENTAL

2,000 IU Vitamin D3 per day

Dietary Supplement: Vitamin D

Interventions

Vitamin D DIETARY_SUPPLEMENT

2,000 IU/ day of Vitamin D3

Vitamin D

Placebo DIETARY_SUPPLEMENT

Placebo

Placebo

Eligibility Criteria

• Age: 65 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Institute on Aging (NIA): collaborator
• Office of Dietary Supplements (ODS): collaborator

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (1)

• Houston DK, Marsh AP, Neiberg RH, Demons JL, Campos CL, Kritchevsky SB, Delbono O, Tooze JA. Vitamin D Supplementation and Muscle Power, Strength and Physical Performance in Older Adults: A Randomized Controlled Trial. Am J Clin Nutr. 2023 Jun;117(6):1086-1095. doi: 10.1016/j.ajcnut.2023.04.021. Epub 2023 Apr 19.

  PMID: 37084814 DERIVED

MeSH Terms

Interventions

Vitamin D

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Denise Houston
• Organization: Wake Forest University School of Medicine

dhouston@wakehealth.edu

336-713-8217

Study Officials

• Denise K Houston, PhD, RD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2013
• First Posted: December 19, 2013
• Study Start: December 1, 2013
• Primary Completion: September 26, 2018
• Study Completion: September 26, 2018
• Last Updated: November 15, 2022
• Results First Posted: November 15, 2022

Record last verified: 2022-09

Locations

US (1)