Vitamin D Supplementation in Older Women

Completed · Not applicable · Has a placebo group

Conditions studied: Osteoporosis, Aging

In brief

The purpose of this study is to examine the effects of several doses of vitamin D on hormones related to bone, calcium absorption, bone density and muscle strength.

Key facts

Study ID

NCT00472823

Run by

Creighton University

People needed

273

Starts

2007-04-01

Expected to finish

2011-08-01

Last updated by the study team

2016-03-14

Who can join

Age: 57 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• At least 7 years post-menopause
• Serum 25OHD level 5 ng/ml to 20 ng/ml
• BMI less than or equal to 40 kg/m2
• Willing to discontinue multivitamins that contain vitamin D during the study

You may not qualify if…

• Cancer (except basal cell carcinoma) or terminal illness
• Previous hip fracture
• Hemiplegia (paralysis of one side of the body)
• Uncontrolled type I diabetes or fasting blood sugar greater than 140 mg in type II
• Kidney stones more than twice in a lifetime
• Chronic renal failure
• Evidence of chronic liver disease, including alcoholism
• Physical conditions such as severe osteoarthritis, rheumatoid arthritis, heart failure severe enough to prevent reasonable physical activity
• Previous treatment with bisphosphonates (more that 3 months), PTH or PTH derivatives, (e.g. Teriparatide or Fluoride) in the last 6 months
• Previous treatment within the last 6 months with calcitonin or estrogen
• Chronic high dose corticosteroid therapy (more than 10 mg per day) for over 6 months and not within the last 6 months
• Anticonvulsant therapy
• High dose thiazide therapy (more than 37.5 mg)
• 24 hour urine calcium greater than 290 mg on 2 baseline tests
• Serum calcium exceeding upper normal limit on 2 baseline tests
• Bone Mineral Density T-score less than -3.0 for spine or hip

Where it is running

• Creighton University Medical Center — Omaha, Nebraska, United States

Full record on ClinicalTrials.gov

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