Vitamin Deficiency in Immigrants, a Treatment Study

Vitamin D Deficiency Clinical Trial

— VIDI2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01419119
• Other study ID #: VIDI 2
• Status: Completed
• Phase: Phase 4
• First received: August 16, 2011
• Last updated: December 10, 2012
• Start date: September 2011
• Est. completion date: October 2012

Study information

• Verified date: December 2012
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vitamin D Deficiency

Intervention

Drug:
• Cholecalciferol
10 000 IU daily i.e. 15 drops orally once daily for 12 weeks
• Cholecalciferol
2000 IU daily i.e. 3 drops orally once a day for 12 weeks,
• Cholecalciferol
2000 IU once a week i.e. 3 drops orally once a week (the same day every week) for 12 weeks,
• Cholecalciferol
2000 IU daily i.e. 3 drops orally once daily for 12 weeks

Locations

Country	Name	City	State
Sweden	Ålidhems hälsocentral, Umeå	Umeå

Sponsors (1)

Lead Sponsor	Collaborator
Umeå University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum-vitamin D	Levels of serum vitamin D3 and Serum -parathyroid hormone(PTH) are to be measured	12 weeks after treatment start	No
Secondary	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	No