Clinical Approaches to Correcting Vitamin D Inadequacy and Maintaining Adequacy
Information source: University of Wisconsin, Madison
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Vitamin D Inadequacy; Vitamin D Deficiency
Intervention: Cholecalciferol (vitamin D3) (Dietary Supplement); Ergocalciferol (vitamin D2) (Dietary Supplement); Ergocalciferol (vitamin D2) (Dietary Supplement); Cholecalciferol (vitamin D3) (Dietary Supplement); Placebo (Dietary Supplement)
Status: Active, not recruiting
Sponsored by: University of Wisconsin, Madison
Official(s) and/or principal investigator(s):
Neil Binkley, MD, Principal Investigator, Affiliation: University of Wisconsin - Institute on Aging
Vitamin D is available in two forms, vitamin D2 and vitamin D3. It has previously been
assumed that these two forms maintain blood vitamin D equally. However, this may not be the
case. This study will evaluate whether D2 and D3 produce equal elevation of blood vitamin D.
Additionally, it will evaluate whether once per month vitamin D dosing is as effective in
maintaining blood vitamin D levels as daily dosing.
Official title: Clinical Approaches to Correcting Vitamin D Inadequacy and Maintaining Adequacy
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Primary outcome: The primary outcome measure is change in 25OHD with various D2 and D3 dosing regimens.
Determine whether once monthly vitamin D2 or D3 dosing is as effective as daily dosing in attainment, and subsequent maintenance, of 25OHD status
Delineate the effect of these vitamin D regimens on other parameters of skeletal relevance
Minimum age: 65 Years.
Maximum age: N/A.
1. Community dwelling men and women age ≥ 65 years.
2. Able and willing to sign informed consent.
3. Serum 25OHD concentration ≥ 10 and less than 60 ng/ml by HPLC.
4. Willing to avoid use of cod-liver oil and non-study vitamin D supplementation;
standard multiple vitamins containing ≤ 400 IU used no more than once daily will be
1. Current hypercalcemia (serum calcium > 10. 5 mg/dl) or untreated primary
2. History of nephrolithiasis.
3. Screening 25OHD concentration ≥ 60 ng/ml.
4. Baseline 24-hour urine calcium > 250 mg if female, > 300 mg if male.
5. Known risk factors for hypercalcemia, e. g., malignancy, tuberculosis, sarcoidosis,
6. History of any form of cancer within the past five years with the exception of
adequately treated squamous cell or basal cell skin cancer.
7. Renal failure defined as a calculated creatinine clearance (Cockroft-Gault method) ≤
8. Severe end-organ disease, e. g., cardiovascular, hepatic, hematologic, pulmonary, etc.,
which may limit ability to complete the study
9. Known malabsorption syndromes, e. g., celiac disease, radiation enteritis, active
inflammatory bowel disease, etc.
10. Use of medications known to alter bone turnover including bisphosphonates, estrogen,
selective estrogen receptor modulators, PTH, testosterone or calcitonin
11. Vitamin D intake greater than 5,000 IU daily
12. Treatment with any active metabolites of vitamin D within six months of screening
13. Treatment with any drug which may interfere with vitamin D metabolism, e. g.,
Locations and Contacts
UW Osteoporosis Clinical and Research Program, Madison, Wisconsin 53705, United States
Starting date: February 2007
Last updated: June 5, 2008