Status:
COMPLETED
A Pilot Study of the Impact of Vitamin D3 on Muscle Performance in Elderly Women
Lead Sponsor:
Tufts University
Collaborating Sponsors:
National Institute on Aging (NIA)
Boston Medical Center
Conditions:
Sarcopenia
Falls
Eligibility:
FEMALE
65+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00986596
Start Date
October 1 2006
End Date
February 1 2011
Last Update
January 10 2012
Active Locations (1)
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1
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
Boston, Massachusetts, United States, 02111