Clinical Approaches to Correcting Vitamin D Inadequacy and Maintaining Adequacy
NCT ID: NCT00692120
Last Updated: 2015-10-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
64 participants
INTERVENTIONAL
2007-02-28
2008-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Vitamin D Inadequacy in Rural Populations, Evaluation of Correction by Food Supplementation
NCT00690417
Improving the Understanding of the Response to Vitamin D Supplementation
NCT01465178
Correction of Vitamin D Inadequacy in Nursing Home Residents
NCT00204906
Effects of Vitamin D Insufficiency in Man
NCT01848236
Treatment of Vitamin D Insufficiency
NCT00933244
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Ergocalciferol (vitamin D2)
oral capsule 50,000 IU once monthly for 12 months
Placebo
oral placebo capsule once daily for 12 months
2
Ergocalciferol (vitamin D2)
oral capsule 1600 IU once daily for 12 months
Placebo
oral placebo capsule once daily for 12 months
3
Cholecalciferol (vitamin D3)
50,000 IU once monthly for 12 months
Placebo
oral placebo capsule once daily for 12 months
4
Cholecalciferol (vitamin D3)
oral capsule 1600 IU once daily for 12 months
Placebo
oral placebo capsule once daily for 12 months
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Wisconsin, Madison
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Neil Binkley, MD
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin - Institute on Aging
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UW Osteoporosis Clinical and Research Program
Madison, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Binkley N, Gemar D, Engelke J, Gangnon R, Ramamurthy R, Krueger D, Drezner MK. Evaluation of ergocalciferol or cholecalciferol dosing, 1,600 IU daily or 50,000 IU monthly in older adults. J Clin Endocrinol Metab. 2011 Apr;96(4):981-8. doi: 10.1210/jc.2010-0015. Epub 2011 Feb 2.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2006-0013
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.