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Completed

NCT Number: NCT01419119

Vitamin Deficiency in Immigrants, a Treatment Study

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.

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Key information

Conditions

Vitamin D Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ålidhems hälsocentral, Umeå

Umeå, Se-90736, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cholecalciferol high dose at Vitamin D deficiency

Drug

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

Other names: Vigantol Oil 20 000 IU/ml, drops for oral use, solution

Cholecalciferol median dose at Vitamin D insufficiency

Drug

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

Other names: Vigantol Oil 20 000 IU/ml, drops for oral use, solution

Cholecalciferol low dose at Vitamin D deficiency

Drug

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

Other names: Vigantol Oil 20 000 IU/ml, drops for oral use, solution

Cholecalciferol median dose at sufficient Vitamin D level

Drug

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

Other names: Vigantol Oil 20 000 IU/ml, drops for oral use, solution

Primary outcomes

  1. Serum-vitamin D

    Time frame: Baseline

    Levels of serum vitamin D3

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

    Time frame: End of treatment period 12 weeks after baseline

    Serum Vitamin D, 25-(OH)D

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Registry information

Official study 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

Acronym: VIDI2

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 17, 2011
Registry last updated
Jul 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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