Vitamin D Supplementation and Physical Function in Older Adults

Physical Function Clinical Trial

Official title:

Vitamin D Supplementation, Skeletal Muscle Gene Expression, and Physical Performance in Older Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01179503
• Other study ID #: IRB00011371
• Secondary ID: R01AG029364-03S1
• Status: Completed
• Phase: Early Phase 1
• Start date: January 2010
• Est. completion date: May 2011

Study information

• Verified date: August 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A growing body of evidence suggests that vitamin D status is important in biologic processes involved in the maintenance of physical function. To advance the investigators understanding of the role of vitamin D in physical function, the investigators will conduct a feasibility pilot study to collect key information to help design a full-scale randomized trial to determine whether vitamin D supplementation will delay declines in physical function. The primary goals of the pilot study are to determine cost-effective strategies for identifying persons at high risk for functional decline with insufficient vitamin D levels, determine the serum vitamin D response to a vitamin D supplementation regimen designed to attain sufficient vitamin D levels, and provide preliminary data of key functional measures (balance, physical performance and muscle power) for the future larger study design. A secondary goal is to begin to examine potential mechanisms by which vitamin D supplementation may enhance physical performance by exploring the effects of vitamin D supplementation on changes in skeletal muscle gene expression.

Description:

A growing body of evidence suggests that vitamin D status is important in biologic processes involved in the maintenance of physical function. However, whether remediation of vitamin D insufficiency will improve physical function and the potential mechanisms involved are unclear. Previous vitamin D supplementation trials have produced mixed results with respect to physical function; however, most trials did not specifically recruit individuals who were vitamin D insufficient nor is the potential mechanism of action understood well enough to appropriately select those individuals most likely to benefit. To advance our understanding of the role of vitamin D in physical function, the investigators will conduct a feasibility pilot study to collect key information to help design a full-scale randomized trial to determine whether vitamin D supplementation will delay declines in physical function. The primary goals of the pilot study are to determine cost-effective strategies for identifying persons at high risk for functional decline with insufficient vitamin D levels, determine the serum vitamin D response to a vitamin D supplementation regimen designed to attain sufficient vitamin D levels, and provide preliminary data of key functional measures (balance, short physical performance battery (SBBP) and muscle power) for the future larger study design. A secondary goal is to begin to examine potential mechanisms by which vitamin D supplementation may enhance physical performance and muscle contractility by exploring the effects of vitamin D supplementation on changes in skeletal muscle gene expression using microarrays.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 70 Years to 89 Years

Eligibility

Inclusion Criteria:

• Short Physical Performance Battery (SPPB) score of = 4 to < 10

• Vitamin D insufficient (serum 25(OH)D = 10 to < 25 ng/mL)

Exclusion Criteria:

• Serious or uncontrolled chronic disease including: insulin-dependent or uncontrolled diabetes; cancer requiring treatment in past year, except non-melanoma skin cancers; past or current ischemic heart disease, uncontrolled angina, heart failure, peripheral artery disease (PAD), or stroke; chronic respiratory disease; uncontrolled endocrine/metabolic disease; neurological or hematological disease; liver or renal dysfunction; and severe musculoskeletal impairment

• Impaired cognitive function (MMSE = 24)

• Dependent on a cane or walker

• Use of anti-coagulants

• Unwillingness to undergo a muscle biopsy

• Taking prescription vitamin D2 or OCT vitamin D3 supplements of > 1000 IU/d

• Inability or contraindications to consume daily vitamin D and calcium supplements

• Weight loss of = 5% or more in the past 6 months

• Involved in any other intervention

Related Conditions & MeSH terms

• Physical Function
• Vitamin D Insufficiency

Intervention

Dietary Supplement:
• calcium
600 mg calcium carbonate twice daily (total of 1200 mg/day) for 4 months
• Vitamin D plus calcium
1000 IU of vitamin D3 twice daily (for a total of 2000 IU/day) plus 600 mg calcium carbonate twice daily (for a total of 1200 mg/day)

Locations

Country	Name	City	State
United States	Wake Forest University	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Physical performance	Change in the expanded Short Physical Performance Battery (SPPB) score (composite score including the following: timed 4m walk; time to stand from a chair 5 times without the use of arms; and time to hold side-by-side, semi-tandem, tandem, and one legged stands for the testing of balance)	4 months
Secondary	Skeletal muscle gene expression	Muscle will be obtained from the vastus lateralis using the percutaneous needle biopsy technique. Five µg of RNA will be supplied for each experimental condition to be analyzed. The WFUHS MicroArray Core Facility further purifies the provided RNA over an RNAeasy column and performs all subsequent steps of the GeneChip protocol (cDNA generation, generation of biotinylated cRNA, chip hybridization, and generation of .CEL files).	4 months
Secondary	Change in expanded SPPB balance task time	Change in expanded SPPB balance task time (time to hold side-by-side, semi-tandem, tandem, and one legged stands; max of 30 sec)	4 months
Secondary	Change in narrow 4m walk test of balance time	Change in time to complete narrow 4m walk test of balance (usual pace over 4m while staying between lines of colored tape placed 20cm apart)	4 months
Secondary	Change in 400m walk test time	Change in 400m walk test time (usual pace)	4 months
Secondary	Change in knee extensor power	Change in knee extensor power measured by the Nottingham Power Rig	4 months