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

Completed · Not applicable · Has a placebo group

Conditions studied: Sarcopenia, Falls

In brief

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

Key facts

Study ID

NCT00986596

Run by

Tufts University

People needed

24

Starts

2006-10-01

Expected to finish

2011-02-01

Last updated by the study team

2012-01-10

Who can join

Age: 65 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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