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

This study has been completed.
Sponsor:
Collaborators:
Boston Medical Center
Information provided by (Responsible Party):
Bess Dawson-Hughes, Tufts University
ClinicalTrials.gov Identifier:
NCT00986596
First received: September 29, 2009
Last updated: January 6, 2012
Last verified: January 2012

September 29, 2009
January 6, 2012
October 2006
February 2011   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00986596 on ClinicalTrials.gov Archive Site
  • Define and compare vitamin D signaling in muscle biopsy specimens taken before and after the treatment. [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Define and compare changes in clinical measures of muscle performance before and after treatment [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Define and compare levels of bone turnover before and after treatment [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Pilot Study of the Impact of Vitamin D3 on Muscle Performance in Elderly Women
A Pilot Study of the Impact of Vitamin D3 on Muscle Performance in Elderly Women

The purpose of the study is to investigate the effect of vitamin D on muscle tissue and physical performance.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Sarcopenia
  • Falls
  • Dietary Supplement: vitamin D3
    4000 IU once daily by mouth for 4 months
  • Dietary Supplement: Placebo
    microcrystalline cellulose capsule p.o. daily (identical to vitamin D capsule)
  • Active Comparator: vitamin D3
    vitamin D3 capsule 4000 IU p.o. daily
    Intervention: Dietary Supplement: vitamin D3
  • Placebo Comparator: placebo
    microcrystalline cellulose capsule p.o. daily (identical to vitamin D capsule)
    Intervention: Dietary Supplement: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
February 2011
February 2011   (final data collection date for primary outcome measure)

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
Female
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00986596
2450, 7528
No
Bess Dawson-Hughes, Tufts University
Tufts University
  • National Institute on Aging (NIA)
  • Boston Medical Center
Principal Investigator: Bess Dawson-Hughes, MD Tufts University
Study Director: Lisa Ceglia, MD Tufts University
Tufts University
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP