Full Text View
Tabular View
No Study Results Posted
Related Studies
Clinical Approaches to Correcting Vitamin D Inadequacy and Maintaining Adequacy (D2/D3)
This study is ongoing, but not recruiting participants.
Study NCT00692120   Information provided by University of Wisconsin, Madison
First Received: January 2, 2008   Last Updated: June 5, 2008   History of Changes

January 2, 2008
June 5, 2008
February 2007
November 2008   (final data collection date for primary outcome measure)
The primary outcome measure is change in 25OHD with various D2 and D3 dosing regimens. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00692120 on ClinicalTrials.gov Archive Site
  • Determine whether once monthly vitamin D2 or D3 dosing is as effective as daily dosing in attainment, and subsequent maintenance, of 25OHD status [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Delineate the effect of these vitamin D regimens on other parameters of skeletal relevance [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Same as current
 
Clinical Approaches to Correcting Vitamin D Inadequacy and Maintaining Adequacy
Clinical Approaches to Correcting Vitamin D Inadequacy and Maintaining Adequacy

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.

 
 
Interventional
Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
  • Vitamin D Inadequacy
  • Vitamin D Deficiency
  • Dietary Supplement: Cholecalciferol (vitamin D3)
  • Dietary Supplement: Ergocalciferol (vitamin D2)
  • Dietary Supplement: Placebo
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
64
 
November 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  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 allowed

Exclusion Criteria:

  1. Current hypercalcemia (serum calcium > 10.5 mg/dl) or untreated primary hyperparathyroidism.
  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, Paget's disease
  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) ≤ 25 ml/minute
  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., phenobarbital, phenytoin.
Both
65 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00692120
Neil Binkley, MD, University of Wisconsin - Institute on Aging
2006-0013
University of Wisconsin, Madison
 
Principal Investigator: Neil Binkley, MD University of Wisconsin - Institute on Aging
University of Wisconsin, Madison
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP