Vitamin Deficiency in Immigrants, a Treatment Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Vitamin D Deficiency

Intervention / Treatment
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* Drug: Cholecalciferol
* Drug: Cholecalciferol
* Drug: Cholecalciferol
* Drug: Cholecalciferol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Vitamin D3, 10 000 IU daily. Treatment to patients with Serum-vitamin D levels below 25 nmol/L | Drug: Cholecalciferol<br>* 10 000 IU daily i.e. 15 drops orally once daily for 12 weeks<br>* Other names: Vigantol Oil 20 000 IU/ml, drops for oral use, solution;|
| Experimental: Group 2a<br>Vitamin D3 2000 IU daily, one of two arms that patients with Serum-vitamin D levels between 25 nmol/L and 49 nmol/l will be randomised to | Drug: Cholecalciferol<br>* 2000 IU daily i.e. 3 drops orally once a day for 12 weeks,<br>* Other names: Vigantol Oil 20 000 IU/ml, drops for oral use, solution;|
| Experimental: Group 2b<br>Vitamin D3 2000 IU weekly, one of two arms that patients with Serum-vitamin D levels between 25 nmol/L and 49 mol/l will be randomised to | Drug: Cholecalciferol<br>* 2000 IU once a week i.e. 3 drops orally once a week (the same day every week) for 12 weeks,<br>* Other names: Vigantol Oil 20 000 IU/ml, drops for oral use, solution;|
| Experimental: Group 3<br>Vitamin D3, 2000 IU daily i.e. 3 drops orally once daily for 12 weeks, treatment to patients with Serum-vitamin D levels between 50 and 74 nmol/L | Drug: Cholecalciferol<br>* 2000 IU daily i.e. 3 drops orally once daily for 12 weeks<br>* Other names: Vigantol Oil 20 000 IU/ml, drops for oral use, solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum-vitamin D | Levels of serum vitamin D3 and Serum -parathyroid hormone(PTH) are to be measured | 12 weeks after treatment start | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle strengths in hands and legs | Muscle strength in hand is measured with JAMAR dynamometer. Muscle strength in lower legs is measured with Balance test by Ekdahl. Quality of life questionaries will also be used. | 12 weeks after start of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vitamin D insufficiency, Cholecalciferol, D3, Parathyroid Hormone, 25-hydroxyvitamin D3, RDA, recommended daily intake (nutrition policy), Vitamin D, Hypovitaminosis-D, Pharmacologic treatment