Vitamin Deficiency in Immigrants, a Treatment Study (VIDI2)

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

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.

Study Overview

• Status: Completed
• Conditions: Vitamin D Deficiency
• Intervention / Treatment: 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

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 Type: Interventional
• Enrollment (Actual): 160
• Phase: Phase 4

Contacts and Locations

Study Locations

• Sweden
  • Umeå, Sweden, Se-90736
    • Ålidhems hälsocentral, Umeå

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

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

Collaborators and Investigators

• Sponsor: Umeå University
• Investigators: Principal Investigator: Margareta Norberg, M.D. Ph.D, Dept of Epidemiology and Global Health, Umeå University

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: August 16, 2011
• First Submitted That Met QC Criteria: August 16, 2011
• First Posted (Estimated): August 17, 2011

Study Record Updates

• Last Update Posted (Actual): July 18, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Vitamin D; Cholecalciferol; Parathyroid Hormone; vitamin D insufficiency; D3; 25-hydroxyvitamin D3; Pharmacologic treatment; RDA, recommended daily intake (nutrition policy); Hypovitaminosis-D
• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin D Deficiency; Physiological Effects of Drugs; Micronutrients; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol; Pharmaceutical Solutions; Vitamins; Ergocalciferols
• Other Study ID Numbers: VIDI 2