Clinical Approaches to Correcting Vitamin D Inadequacy and Maintaining Adequacy (D2/D3)

This study has been completed.
Sponsor:
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00692120
First received: January 2, 2008
Last updated: April 5, 2010
Last verified: April 2010
  Purpose

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.


Condition Intervention
Vitamin D Inadequacy
Vitamin D Deficiency
Dietary Supplement: Cholecalciferol (vitamin D3)
Dietary Supplement: Ergocalciferol (vitamin D2)
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Approaches to Correcting Vitamin D Inadequacy and Maintaining Adequacy

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • The primary outcome measure is change in 25OHD with various D2 and D3 dosing regimens. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 64
Study Start Date: February 2007
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Dietary Supplement: Ergocalciferol (vitamin D2)
oral capsule 50,000 IU once monthly for 12 months
Dietary Supplement: Placebo
oral placebo capsule once daily for 12 months
Experimental: 2 Dietary Supplement: Ergocalciferol (vitamin D2)
oral capsule 1600 IU once daily for 12 months
Dietary Supplement: Placebo
oral placebo capsule once daily for 12 months
Experimental: 3 Dietary Supplement: Cholecalciferol (vitamin D3)
50,000 IU once monthly for 12 months
Dietary Supplement: Placebo
oral placebo capsule once daily for 12 months
Experimental: 4 Dietary Supplement: Cholecalciferol (vitamin D3)
oral capsule 1600 IU once daily for 12 months
Dietary Supplement: Placebo
oral placebo capsule once daily for 12 months

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00692120

Locations
United States, Wisconsin
UW Osteoporosis Clinical and Research Program
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Neil Binkley, MD University of Wisconsin - Institute on Aging
  More Information

No publications provided by University of Wisconsin, Madison

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Neil Binkley, MD, University of Wisconsin - Institute on Aging
ClinicalTrials.gov Identifier: NCT00692120     History of Changes
Other Study ID Numbers: 2006-0013
Study First Received: January 2, 2008
Last Updated: April 5, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Cholecalciferol
Ergocalciferols
Vitamin D
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on July 22, 2014