Vitamin Deficiency in Immigrants, a Treatment Study (VIDI2)

• ClinicalTrials.gov Identifier: NCT01419119
• Recruitment Status: Completed
• First Posted: August 17, 2011
• Last Update Posted: December 11, 2012
• Sponsor: Umeå University
• Information provided by (Responsible Party): Margareta Norberg, Umeå University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Vitamin D Deficiency	Drug: Cholecalciferol	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 160 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: September 2011
• Actual Primary Completion Date: October 2012
• Actual Study Completion Date: October 2012

Arms and Interventions

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; 10 000 IU daily i.e. 15 drops orally once daily for 12 weeks; Other Name: 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; 2000 IU daily i.e. 3 drops orally once a day for 12 weeks,; Other Name: 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; 2000 IU once a week i.e. 3 drops orally once a week (the same day every week) for 12 weeks,; Other Name: 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; 2000 IU daily i.e. 3 drops orally once daily for 12 weeks; Other Name: Vigantol Oil 20 000 IU/ml, drops for oral use, solution

Outcome Measures

Primary Outcome Measures :

1. Serum-vitamin D [ Time Frame: 12 weeks after treatment start ]
   Levels of serum vitamin D3 and Serum -parathyroid hormone(PTH) are to be measured

Secondary Outcome Measures :

1. Muscle strengths in hands and legs [ Time Frame: 12 weeks after start of treatment ]

   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.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

Sweden

Ålidhems hälsocentral, Umeå

Umeå, Sweden, Se-90736

Sponsors and Collaborators

Umeå University

Investigators

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

More Information

• Responsible Party: Margareta Norberg, M.D. Ph.D., Umeå University
• ClinicalTrials.gov Identifier: NCT01419119
• Other Study ID Numbers: VIDI 2
• First Posted: August 17, 2011
• Last Update Posted: December 11, 2012
• Last Verified: December 2012

Keywords provided by Margareta Norberg, Umeå University:

vitamin D insufficiency; Cholecalciferol; D3; Parathyroid Hormone; 25-hydroxyvitamin D3; RDA, recommended daily intake (nutrition policy); Vitamin D; Hypovitaminosis-D; Pharmacologic treatment

Additional relevant MeSH terms:

Vitamin D Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Cholecalciferol; Pharmaceutical Solutions; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Vitamins; Micronutrients; Nutrients; Growth Substances; Bone Density Conservation Agents