search
Back to results

A Pilot Study of the Impact of Vitamin D3 on Muscle Performance in Elderly Women

Primary Purpose

Sarcopenia, Falls

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
vitamin D3
Placebo
Sponsored by
Tufts University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcopenia focused on measuring vitamin D, skeletal muscle, vitamin D receptor

Eligibility Criteria

65 Years - undefined (Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 65 and older
  • 25 (OH)D levels >22.5 nmol/l or <60 nmol/l
  • Women must have a composite physical performance score of ≤ 9 out of a possible score of 12.
  • Subjects must agree not to change their usual level of physical activity or change the amount of calcium and vitamin D supplement they use for the duration of the study.
  • If they are taking calcium supplements, they must agree to take the supplement any time after lunch.

Exclusion Criteria:

  • General:

    1. Total calcium intake >1000mg daily on the prescreening questionnaire.
    2. More than 400 IU daily of supplemental vitamin D on the prescreening questionnaire.
    3. A screening 25(OH)D level > 60 nmol/ L.
    4. Screening 24-hour urine calcium > 275 mg.
    5. An abnormal serum calcium.
    6. Travel to latitude <35 degrees N within 2 months of the time of enrollment; plans to travel to latitude <35 degrees N during the 4-month study, with the likelihood of tanning (e.g. appreciable sun exposure without sun screen).
    7. Greater than 2 drinks of alcohol a day.

  • Medications:

    1. Bone active drugs such as bisphosphonates, estrogen, calcitonin, teriparatide
    2. Diuretics
    3. Oral glucocorticoids in the last month
    4. Phosphates in the last week
    5. Lithium
    6. Cod liver oil
    7. Total parenteral nutrition
    8. Calcium containing antacids
    9. Coumadin or other prescribed anticoagulants

  • Diseases:

    1. Active thyroid disease - unstable levothyroxine dose
    2. Parathyroid disease
    3. Sarcoidosis
    4. Fracture of the foot, leg, or hip in the last year
    5. Renal stone < 5 years
    6. Alkaline phosphatase > 10% above the upper limit of normal
    7. Pancreatitis
    8. Active malignancy (other than basal cell cancer of the skin) or cancer therapy in the last year
    9. Uncontrolled arrhythmia in last year
    10. Malabsorption
    11. Use of a walker or wheelchair (3-post cane okay)
    12. Nasal oxygen use
    13. Must have a basic mobility level of walking 4 meters
    14. Hemiplegia
    15. Tuberculosis
    16. Type 1 Diabetes mellitus or unstable type 2 diabetes mellitus (fasting blood glucose >130 mg/dL)
    17. Other abnormality in screening labs, at the discretion of the study physician

Sites / Locations

  • Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

vitamin D3

placebo

Arm Description

vitamin D3 capsule 4000 IU p.o. daily

microcrystalline cellulose capsule p.o. daily (identical to vitamin D capsule)

Outcomes

Primary Outcome Measures

Define and compare changes in size and number of type II muscle fibers in response to 4 months of treatment with 4000 IU of vitamin D3 per day or placebo in older women with low-normal 25(OH)D levels.

Secondary Outcome Measures

Define and compare vitamin D signaling in muscle biopsy specimens taken before and after the treatment.
Define and compare changes in clinical measures of muscle performance before and after treatment
Define and compare levels of bone turnover before and after treatment

Full Information

First Posted
September 29, 2009
Last Updated
January 6, 2012
Sponsor
Tufts University
Collaborators
National Institute on Aging (NIA), Boston Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT00986596
Brief Title
A Pilot Study of the Impact of Vitamin D3 on Muscle Performance in Elderly Women
Official Title
A Pilot Study of the Impact of Vitamin D3 on Muscle Performance in Elderly Women
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tufts University
Collaborators
National Institute on Aging (NIA), Boston Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the study is to investigate the effect of vitamin D on muscle tissue and physical performance.
Detailed Description
The investigators have recently observed that among healthy women age 65 and older who participated in a placebo-controlled vitamin D and calcium intervention trial, those treated with supplements had a lower risk of falling than those in the placebo group. Vitamin D receptors (VDRs) are present in muscle tissue and are thought to mediate the favorable effects of vitamin D on muscle performance. Vitamin D insufficiency is common particularly in the elderly and supplementation with a relatively high dose of vitamin D may be a useful approach for improving muscle performance and potentially lowering the risk of falling in sedentary older women and other high-risk populations. The investigators will aim to study women, age 65 and older, with 25(OH)D levels below 60 nmol/l in a double-blind, 4-month randomized controlled pilot study. Eligible subjects will be randomized to treatment with 4000 IU per day of vitamin D3 or placebo. Blood and 24 hour urine will be measured at the beginning and end of the study as outlined in the intervention and measurement schedule below. In addition, a safety random spot urine will be analyzed for calcium and creatinine on day 30. Muscle performance measures will be measured and muscle biopsies will be performed at the beginning and end of the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia, Falls
Keywords
vitamin D, skeletal muscle, vitamin D receptor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
vitamin D3
Arm Type
Active Comparator
Arm Description
vitamin D3 capsule 4000 IU p.o. daily
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
microcrystalline cellulose capsule p.o. daily (identical to vitamin D capsule)
Intervention Type
Dietary Supplement
Intervention Name(s)
vitamin D3
Intervention Description
4000 IU once daily by mouth for 4 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
microcrystalline cellulose capsule p.o. daily (identical to vitamin D capsule)
Primary Outcome Measure Information:
Title
Define and compare changes in size and number of type II muscle fibers in response to 4 months of treatment with 4000 IU of vitamin D3 per day or placebo in older women with low-normal 25(OH)D levels.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Define and compare vitamin D signaling in muscle biopsy specimens taken before and after the treatment.
Time Frame
4 months
Title
Define and compare changes in clinical measures of muscle performance before and after treatment
Time Frame
4 months
Title
Define and compare levels of bone turnover before and after treatment
Time Frame
4 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 65 and older 25 (OH)D levels >22.5 nmol/l or <60 nmol/l Women must have a composite physical performance score of ≤ 9 out of a possible score of 12. Subjects must agree not to change their usual level of physical activity or change the amount of calcium and vitamin D supplement they use for the duration of the study. If they are taking calcium supplements, they must agree to take the supplement any time after lunch. Exclusion Criteria: General: Total calcium intake >1000mg daily on the prescreening questionnaire. More than 400 IU daily of supplemental vitamin D on the prescreening questionnaire. A screening 25(OH)D level > 60 nmol/ L. Screening 24-hour urine calcium > 275 mg. An abnormal serum calcium. Travel to latitude <35 degrees N within 2 months of the time of enrollment; plans to travel to latitude <35 degrees N during the 4-month study, with the likelihood of tanning (e.g. appreciable sun exposure without sun screen). Greater than 2 drinks of alcohol a day. Medications: Bone active drugs such as bisphosphonates, estrogen, calcitonin, teriparatide Diuretics Oral glucocorticoids in the last month Phosphates in the last week Lithium Cod liver oil Total parenteral nutrition Calcium containing antacids Coumadin or other prescribed anticoagulants Diseases: Active thyroid disease - unstable levothyroxine dose Parathyroid disease Sarcoidosis Fracture of the foot, leg, or hip in the last year Renal stone < 5 years Alkaline phosphatase > 10% above the upper limit of normal Pancreatitis Active malignancy (other than basal cell cancer of the skin) or cancer therapy in the last year Uncontrolled arrhythmia in last year Malabsorption Use of a walker or wheelchair (3-post cane okay) Nasal oxygen use Must have a basic mobility level of walking 4 meters Hemiplegia Tuberculosis Type 1 Diabetes mellitus or unstable type 2 diabetes mellitus (fasting blood glucose >130 mg/dL) Other abnormality in screening labs, at the discretion of the study physician
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bess Dawson-Hughes, MD
Organizational Affiliation
Tufts University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lisa Ceglia, MD
Organizational Affiliation
Tufts University
Official's Role
Study Director
Facility Information:
Facility Name
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Pilot Study of the Impact of Vitamin D3 on Muscle Performance in Elderly Women

We'll reach out to this number within 24 hrs