Vitamin D Supplementation and Physical Function in Older Adults

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Wake Forest School of Medicine
ClinicalTrials.gov Identifier:
NCT01179503
First received: August 10, 2010
Last updated: August 3, 2011
Last verified: February 2011
  Purpose

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.


Condition Intervention
Physical Function
Vitamin D Insufficiency
Dietary Supplement: calcium
Dietary Supplement: Vitamin D plus calcium

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vitamin D Supplementation, Skeletal Muscle Gene Expression, and Physical Performance in Older Adults

Resource links provided by NLM:


Further study details as provided by Wake Forest School of Medicine:

Primary Outcome Measures:
  • Change in Physical performance [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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)


Secondary Outcome Measures:
  • Skeletal muscle gene expression [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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).

  • Change in expanded SPPB balance task time [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Change in expanded SPPB balance task time (time to hold side-by-side, semi-tandem, tandem, and one legged stands; max of 30 sec)

  • Change in narrow 4m walk test of balance time [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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)

  • Change in 400m walk test time [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Change in 400m walk test time (usual pace)

  • Change in knee extensor power [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Change in knee extensor power measured by the Nottingham Power Rig


Enrollment: 16
Study Start Date: January 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Calcium only
1200 mg Calcium per day
Dietary Supplement: calcium
600 mg calcium carbonate twice daily (total of 1200 mg/day) for 4 months
Experimental: Vitamin D plus calcium
2000 IU vitamin D plus 1200 mg calcium per day
Dietary Supplement: 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)

Detailed 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.

  Eligibility

Ages Eligible for Study:   70 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01179503

Locations
United States, North Carolina
Wake Forest University
Winston Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest School of Medicine
Investigators
Study Director: Denise K Houston, PhD Wake Forest School of Medicine
Principal Investigator: Stephen B Kritchevsky, PhD Wake Forest School of Medicine
  More Information

No publications provided

Responsible Party: Stephen B. Kritchevsky, Wake Forest University
ClinicalTrials.gov Identifier: NCT01179503     History of Changes
Other Study ID Numbers: R01 AG029364-03S1, R01AG029364-03S1
Study First Received: August 10, 2010
Last Updated: August 3, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest School of Medicine:
vitamin D
physical performance

Additional relevant MeSH terms:
Calcium, Dietary
Vitamin D
Ergocalciferols
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on August 28, 2014