Vitamin Deficiency in Immigrants, a Treatment Study

Phase 4CompletedNCT01419119

Umeå University160 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

160

Conditions

Vitamin D Deficiency

Interventions

Cholecalciferol high dose at Vitamin D deficiencyDRUG

10 000 IU daily i.e. 15 drops orally once daily for 12 weeks

Cholecalciferol median dose at Vitamin D insufficiencyDRUG

2000 IU daily i.e. 3 drops orally once a day for 12 weeks,

Cholecalciferol low dose at Vitamin D deficiencyDRUG

2000 IU once a week i.e. 3 drops orally once a week (the same day every week) for 12 weeks,

Eligibility

Sex: ALLMin age: 25 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Serum- vitamin D below 75 nmol/L * Men and female * 25-65 years of age * Born in Middle East or Africa, living in Umeå district Exclusion Criteria: * Hypersensitive to Cholecalciferol, cocos oil, palm kernel or rubber * Serum D3 equal to or above75 nmol/L * Hypercalcemia * Renal insufficiency * History of Kidney Calculi * Nephrocalcinosis * History of sarcoidosis and other Granulomatous Diseases * Known malignancy * Ongoing treatment with phenytoin, barbiturates, rifampicin, isoniazid * Ongoing treatment with cardiac glycosides * Ongoing treatment with thiazides * Ongoing treatment with Etalpha, Rocaltrol, ergocalciferol, Dygratal * Ongoing treatment with drugs involving fat absorption; Orlistat Colestyramin * Oral treatment with glucocorticoids * Ongoing treatment with Aluminum Compounds drugs * Ongoing treatment with Omega -3, vitamin D and/or calcium * Immobilisation * Other medial reason not to participate according to the investigator * Pregnancy (women with S-D3 below 25 nmol/) * Breastfeeding

Locations (1)

Ålidhems hälsocentral, Umeå

Umeå, Sweden

Outcomes

Primary Outcomes

Serum-vitamin D

Levels of serum vitamin D3

Time frame: Baseline

Level of Vitamin D at End of the Treatment Period of 12 Weeks

Serum Vitamin D, 25-(OH)D

Time frame: End of treatment period 12 weeks after baseline

Data from ClinicalTrials.gov

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