NCT01419119

Vitamin Deficiency in Immigrants, a Treatment Study

A Study, Four Parallel Arms, Included Two Arms Open Randomisation to Different Doses of Vitamin D, for Assessment of Efficacy of Treatment With Vitamin D at Vitamin D Deficiency, Vitamin D Insufficiency and Suboptimal Levels of Vitamin D

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Umeå University · Academic / Other
• Sex: All
• Age: 25 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the efficacy of different doses of vitamin D in persons, immigrated to Sweden from Middle East or Africa, with decreased S vitamin D.

Detailed description

The participants in the study have taken part in a previous screening study. They are now asked to participate in this treatment study. At a screening visit blood samples for vitamin D3 and PTH are collected. Data regarding previous fractures, life style, exposure for sun, clothes, diet, smoking and physical activities are collected. The Vitamin D value predict the treatment dose.

Conditions

• Vitamin D Deficiency

Interventions

Type	Name	Description
DRUG	Cholecalciferol high dose at Vitamin D deficiency	10 000 IU daily i.e. 15 drops orally once daily for 12 weeks
DRUG	Cholecalciferol median dose at Vitamin D insufficiency	2000 IU daily i.e. 3 drops orally once a day for 12 weeks,
DRUG	Cholecalciferol low dose at Vitamin D deficiency	2000 IU once a week i.e. 3 drops orally once a week (the same day every week) for 12 weeks,
DRUG	Cholecalciferol median dose at sufficient Vitamin D level	2000 IU daily i.e. 3 drops orally once daily for 12 weeks

Timeline

• Start date: 2011-09-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2011-08-17
• Last updated: 2024-07-18
• Results posted: 2024-07-18

Locations

1 site across 1 country: Sweden