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Vitamin Deficiency in Immigrants, a Treatment Study (VIDI2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Margareta Norberg, Umeå University
ClinicalTrials.gov Identifier:
NCT01419119
First received: August 16, 2011
Last updated: December 10, 2012
Last verified: December 2012
History of Changes
  Purpose

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 Intervention Phase
Vitamin D Deficiency
 Drug: Cholecalciferol
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Vitamin D
U.S. FDA Resources

Further study details as provided by Umeå University:

Primary Outcome Measures:
  • Serum-vitamin D [ Time Frame: 12 weeks after treatment start ] [ Designated as safety issue: No ]
    Levels of serum vitamin D3 and Serum -parathyroid hormone(PTH) are to be measured


Secondary Outcome Measures:
  • Muscle strengths in hands and legs [ Time Frame: 12 weeks after start of treatment ] [ Designated as safety issue: No ]

    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.



Enrollment: 160
Study Start Date: September 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01419119

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

No publications provided

Responsible Party: Margareta Norberg, M.D. Ph.D., Umeå University
ClinicalTrials.gov Identifier: NCT01419119     History of Changes
Other Study ID Numbers: VIDI 2
Study First Received: August 16, 2011
Last Updated: December 10, 2012
Health Authority: Sweden: Medical Products Agency

Keywords provided by 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
Vitamin D
 Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on June 18, 2013