Vitamin Deficiency in Immigrants, a Treatment Study (VIDI2)

Umeå University

Status and phase: Completed; Phase 4

Conditions: Vitamin D Deficiency

Treatments: Drug: Cholecalciferol high dose at Vitamin D deficiency; Drug: Cholecalciferol median dose at Vitamin D insufficiency; Drug: Cholecalciferol low dose at Vitamin D deficiency; Drug: Cholecalciferol median dose at sufficient Vitamin D level

Study type: Interventional

Funder types: Other

Identifiers

NCT01419119

VIDI 2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 patients

Sex: All

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 4 patient groups

Group 1

Experimental group

Description:

Vitamin D3, 10 000 IU daily. Treatment to patients with Serum-vitamin D levels below 25 nmol/L

Treatment:

Drug: Cholecalciferol high dose at Vitamin D deficiency

Group 2a

Experimental group

Description:

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

Treatment:

Drug: Cholecalciferol median dose at Vitamin D insufficiency

Group 2b

Experimental group

Description:

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

Treatment:

Drug: Cholecalciferol low dose at Vitamin D deficiency

Group 3

Experimental group

Description:

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

Treatment:

Drug: Cholecalciferol median dose at sufficient Vitamin D level