Dosage Calculation for Vitamin D Treatment

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02186106
• Other study ID #: H-4-2011-094
• Status: Completed
• Phase: Phase 4
• First received: July 3, 2014
• Last updated: July 7, 2014
• Start date: January 2012
• Est. completion date: September 2013

Study information

• Verified date: July 2014
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The National Committee on Health Research EthicsDenmark: Danish Health and Medicines AuthorityDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: September 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Deficiency, Vitamin D
• Obesity
• Vitamin D Deficiency

Intervention

Drug:
• Cholecalciferol

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bispebjerg Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in baseline value of [25-OH-vitamin-D]		1 week, 3 weeks and 3 months	No