Status:
COMPLETED
Vitamin D Supplementation in Younger Women
Lead Sponsor:
Creighton University
Collaborating Sponsors:
University of Nebraska
Conditions:
Hypovitaminosis D
Eligibility:
FEMALE
25-45 years
Phase:
NA
Brief Summary
That on average it will require a vitamin D dose of 1700IU/day to increase the serum 25hydroxyvitamin D level from 20 to 30ng/ml in young Caucasian women and a dose of 1860 to 2480 IU/day in African A...
Detailed Description
Vitamin D is a unique nutrient in that its requirement can be met by both endogenous production from sun and from diet, which makes it difficult to determine the actual requirements as for other nutri...
Eligibility Criteria
Inclusion
- Premenopausal women, minimum age 25 years, maximum age 45 years. (Women with hysterectomy and/or oophorectomy must have a premenopausal FSH level.)
- Serum 25OHD level: 5 - 20 ng/ml
- BMI \< 45 kg/m2.
- Willing to discontinue vitamin D supplements after entering the study.
- Negative pregnancy test before BMD and calcium absorption tests.
- Willing to give signed informed consent form
- Subject is Caucasian or African American
Exclusion
- Cancer (exceptions: basal cell carcinoma or if cancer occurred more than 10 years ago) or terminal illness.
- Previous hip fracture.
- Hemiplegia.
- Uncontrolled type I diabetes ± significant proteinuria or fasting blood sugar \>140 mg in type II diabetes.
- Kidney stones- \> 2 in a lifetime.
- Chronic renal failure (serum creatinine \>1.4 mg/dl).
- 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 (except birth control pills).
- Chronic high dose corticosteroid therapy (\> 10 mg/day) for over 6 months and not within the last 6 months.
- Anticonvulsant therapy. (Dilantin, Phenobarbital)
- High dose thiazide therapy (\> 37.5 mg).
- 24 hour urine calcium \> 290 mg on 2 baseline tests.
- Serum calcium exceeding upper normal limit on 2 baseline tests.
- BMD. T-score less than -3.0 for spine or hip.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
198 Patients enrolled
Trial Details
Trial ID
NCT00662844
Start Date
April 1 2008
End Date
August 1 2011
Last Update
March 25 2016
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