Vitamin Deficiency in Immigrants, a Treatment Study

NCT01419119 | Completed Phase 4 Results

• 1 other identifier: VIDI 2
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin D Deficiency

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (4)

Group 1

EXPERIMENTAL

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

Group 2a

EXPERIMENTAL

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

Group 2b

EXPERIMENTAL

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

Group 3

EXPERIMENTAL

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

Interventions

Cholecalciferol high dose at Vitamin D deficiency DRUG

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

Also known as: Vigantol Oil 20 000 IU/ml, drops for oral use, solution

Group 1

Cholecalciferol median dose at Vitamin D insufficiency DRUG

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

Also known as: Vigantol Oil 20 000 IU/ml, drops for oral use, solution

Group 2a

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,

Also known as: Vigantol Oil 20 000 IU/ml, drops for oral use, solution

Group 2b

Cholecalciferol median dose at sufficient Vitamin D level DRUG

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

Also known as: Vigantol Oil 20 000 IU/ml, drops for oral use, solution

Group 3

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Serum- vitamin D below 75 nmol/L
• Men and female
• years of age
• Born in Middle East or Africa, living in Umeå district

You may not qualify if:

• 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

Sponsors & Collaborators

• Umeå University: lead

Study Sites (1)

Ålidhems hälsocentral, Umeå

Umeå, Se-90736, Sweden

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Cholecalciferol; Solutions

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Pharmaceutical Preparations

Limitations and Caveats

This open partly RCT was conducted during September 2011-May 2012 at the Umeå University Hospital Clinical Research Centre, monitored by the Clinical Trial Unit, Region Västerbotten, Sweden. The study treatment was vitamin D supplementation (25(OH)D) during 12 weeks. The trial was reported to the Swedish Medical Products Agency in August 2013 and to the European Medicines Agency in November 2021. No reports have been accepted to publication in Scientific journals

Results Point of Contact

• Title: Dr Margareta Norberg
• Organization: Umea University, Umeå, Sweden

margareta.norberg@umu.se

+46702618614

Study Officials

• Margareta Norberg, M.D. Ph.D

  Dept of Epidemiology and Global Health, Umeå University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D. Ph.D.

Study Record Dates

• First Submitted: August 16, 2011
• First Posted: August 17, 2011
• Study Start: September 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: July 18, 2024
• Results First Posted: July 18, 2024

Record last verified: 2024-02

Locations

SE (1)