Clinical Approaches to Correcting Vitamin D Inadequacy and Maintaining Adequacy

Vitamin D Deficiency Clinical Trial

— D2/D3  

Official title:

Clinical Approaches to Correcting Vitamin D Inadequacy and Maintaining Adequacy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00692120
• Other study ID #: 2006-0013
• Status: Completed
• Phase: N/A
• First received: January 2, 2008
• Last updated: October 1, 2015
• Start date: February 2007
• Est. completion date: November 2008

Study information

• Verified date: April 2010
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vitamin D Deficiency
• Vitamin D Inadequacy

Intervention

Dietary Supplement:
• Cholecalciferol (vitamin D3)
50,000 IU once monthly for 12 months
• Ergocalciferol (vitamin D2)
oral capsule 50,000 IU once monthly for 12 months
• Ergocalciferol (vitamin D2)
oral capsule 1600 IU once daily for 12 months
• Cholecalciferol (vitamin D3)
oral capsule 1600 IU once daily for 12 months
• Placebo
oral placebo capsule once daily for 12 months

Locations

Country	Name	City	State
United States	UW Osteoporosis Clinical and Research Program	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome measure is change in 25OHD with various D2 and D3 dosing regimens.		12 months	Yes
Secondary	Determine whether once monthly vitamin D2 or D3 dosing is as effective as daily dosing in attainment, and subsequent maintenance, of 25OHD status		12 months	Yes
Secondary	Delineate the effect of these vitamin D regimens on other parameters of skeletal relevance		12 months	Yes