Dosage Calculation for Vitamin D Treatment

Bispebjerg Hospital

Status and phase: Completed; Phase 4

Conditions: Deficiency, Vitamin D; Obesity

Treatments: Drug: Cholecalciferol

Study type: Interventional

Funder types: Other

Identifiers

NCT02186106

H-4-2011-094

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 2 patient groups

Loading dose substitution

Experimental group

Description:

Substituted with a highdose of cholecalciferol at study start

Treatment:

Drug: Cholecalciferol

Historic controls

No Intervention group

Description:

Control subjects from journal archive