Vitamin Deficiency in Immigrants, a Treatment Study

Phase 4

Completed

• Conditions: Vitamin D Deficiency
• Interventions: Drug: Cholecalciferol median dose at Vitamin D insufficiency; Drug: Cholecalciferol high dose at Vitamin D deficiency; Drug: Cholecalciferol median dose at sufficient Vitamin D level; Drug: Cholecalciferol low dose at Vitamin D deficiency

• Registration Number: NCT01419119
• Lead Sponsor: Umeå University

Brief 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.

Study Timeline

• Study First Submitted: 2011-08-16
• Study First Submitted QC: 2011-08-16
• Study First Posted: 2011-08-17
• Study Start: 2011-09
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Results First Submitted: 2023-05-10
• Status Verified: 2024-02
• Results First Submitted QC: 2024-02-05
• Last Update Submitted: 2024-02-05
• Results First Posted: 2024-07-18
• Last Update Posted: 2024-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2a	Cholecalciferol median dose at Vitamin D insufficiency	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
Group 1	Cholecalciferol high dose at Vitamin D deficiency	Vitamin D3, 10 000 IU daily. Treatment to patients with Serum-vitamin D levels below 25 nmol/L
Group 3	Cholecalciferol median dose at sufficient Vitamin D level	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
Group 2b	Cholecalciferol low dose at Vitamin D deficiency	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

Primary Outcome Measures

Name	Time	Method
Serum-vitamin D	Baseline	Levels of serum vitamin D3
Level of Vitamin D at End of the Treatment Period of 12 Weeks	End of treatment period 12 weeks after baseline	Serum Vitamin D, 25-(OH)D

Trial Locations

Locations (1)

Ålidhems hälsocentral, Umeå; 🇸🇪 Umeå, Sweden