Dosage Calculation for Vitamin D Treatment

Phase 4

Completed

• Conditions: Deficiency, Vitamin D; Obesity
• Interventions: Drug: Cholecalciferol

• Registration Number: NCT02186106
• Lead Sponsor: Bispebjerg Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2013-06
• Study Completion: 2013-09
• Status Verified: 2014-07
• Study First Submitted: 2014-07-03
• Study First Submitted QC: 2014-07-07
• Last Update Submitted: 2014-07-07
• Study First Posted: 2014-07-10
• Last Update Posted: 2014-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Loading dose substitution	Cholecalciferol	Substituted with a highdose of cholecalciferol at study start

Primary Outcome Measures

Name	Time	Method
Change in baseline value of [25-OH-vitamin-D]	1 week, 3 weeks and 3 months