Back to resultsDosage Calculation for Vitamin D Treatment
Primary Purpose
Deficiency, Vitamin D, Obesity
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Cholecalciferol
Sponsored by
About this trial
This is an interventional treatment trial for Deficiency, Vitamin D
Eligibility Criteria
Inclusion Criteria:
- severe hypovitaminosis D (25OH-vit.D <25 nmol/L)
Exclusion Criteria:
- Malabsorption
- Renal disease
- Other treatment with vitamin D related products
- Patients with a recent travel history with suspected increased sun exposure
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Loading dose substitution
Historic controls
Arm Description
Substituted with a highdose of cholecalciferol at study start
Control subjects from journal archive
Outcomes
Primary Outcome Measures
Change in baseline value of [25-OH-vitamin-D]
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02186106
Brief Title
Dosage Calculation for Vitamin D Treatment
Official Title
The Effect of Oral Loading Doses of Cholecalciferol on the Serum Concentration of 25-OH-vitamin-D
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bispebjerg Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Severe vitamin D deficiency can be treated with oral loading doses of cholecalciferol. Our objective was to determine how to calculate the quantity of cholecalciferol needed for supplementation by single algorithm, usable on a patient-to-patient basis.
We've conducted two studies. Study 1 was done retroactively and included 88 patients treated for low vitamin D, 60 of those with a loading dose. The second study included 29 patients and aimed to test the validity of an algorithm based on data from study 1, which included patient BMI. Both studies used oral loading doses and daily supplementation of cholecalciferol.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deficiency, Vitamin D, Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Loading dose substitution
Arm Type
Experimental
Arm Description
Substituted with a highdose of cholecalciferol at study start
Arm Title
Historic controls
Arm Type
No Intervention
Arm Description
Control subjects from journal archive
Intervention Type
Drug
Intervention Name(s)
Cholecalciferol
Other Intervention Name(s)
Dekristol capsules of 20.000 IU pr. capsule
Primary Outcome Measure Information:
Title
Change in baseline value of [25-OH-vitamin-D]
Time Frame
1 week, 3 weeks and 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
severe hypovitaminosis D (25OH-vit.D <25 nmol/L)
Exclusion Criteria:
Malabsorption
Renal disease
Other treatment with vitamin D related products
Patients with a recent travel history with suspected increased sun exposure
12. IPD Sharing Statement
Learn more about this trial
Dosage Calculation for Vitamin D Treatment
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