Dosage Calculation for Vitamin D Treatment

July 7, 2014 updated by: Rasmus Bo Jansen, Bispebjerg Hospital

The Effect of Oral Loading Doses of Cholecalciferol on the Serum Concentration of 25-OH-vitamin-D

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Loading dose substitution
Substituted with a highdose of cholecalciferol at study start
Drug: Cholecalciferol
Other Names:
  • Dekristol capsules of 20.000 IU pr. capsule
No Intervention: Historic controls
Control subjects from journal archive

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in baseline value of [25-OH-vitamin-D]
Time Frame: 1 week, 3 weeks and 3 months
1 week, 3 weeks and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bispebjerg Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

July 3, 2014

First Submitted That Met QC Criteria

July 7, 2014

First Posted (Estimate)

July 10, 2014

Study Record Updates

Last Update Posted (Estimate)

July 10, 2014

Last Update Submitted That Met QC Criteria

July 7, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-4-2011-094

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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