NCT01179503

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 11, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

August 17, 2018

Status Verified

August 1, 2018

Enrollment Period

1.3 years

First QC Date

August 10, 2010

Last Update Submit

August 15, 2018

Conditions

Physical FunctionVitamin D Insufficiency

Keywords

vitamin Dphysical performance

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Skeletal muscle gene expression

    4 months

  • Change in expanded SPPB balance task time

    4 months

  • Change in narrow 4m walk test of balance time

    4 months

  • Change in 400m walk test time

    4 months

  • Change in knee extensor power

    4 months

Study Arms (2)

Calcium only

ACTIVE COMPARATOR

1200 mg Calcium per day

Dietary Supplement: calcium

Vitamin D plus calcium

EXPERIMENTAL

2000 IU vitamin D plus 1200 mg calcium per day

Dietary Supplement: Vitamin D plus calcium

Interventions

calciumDIETARY_SUPPLEMENT

600 mg calcium carbonate twice daily (total of 1200 mg/day) for 4 months

Calcium only
Vitamin D plus calciumDIETARY_SUPPLEMENT

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)

Vitamin D plus calcium

Eligibility Criteria

Age70 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Short Physical Performance Battery (SPPB) score of ≥ 4 to \< 10
  • Vitamin D insufficient (serum 25(OH)D ≥ 10 to \< 25 ng/mL)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Interventions

CalciumVitamin D

Intervention Hierarchy (Ancestors)

Metals, Alkaline EarthElementsInorganic ChemicalsMetalsBlood Coagulation FactorsBiological FactorsSecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Denise K Houston, PhD

    Wake Forest University

    STUDY DIRECTOR

  • Stephen B Kritchevsky, PhD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2010

First Posted

August 11, 2010

Study Start

January 1, 2010

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

August 17, 2018

Record last verified: 2018-08

Locations

US(1)