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Vitamin Deficiency in Immigrants, a Treatment Study (VIDI2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01419119
Recruitment Status : Completed
First Posted : August 17, 2011
Last Update Posted : December 11, 2012
Sponsor:
Information provided by (Responsible Party):
Margareta Norberg, Umeå University

Tracking Information
First Submitted Date  ICMJE August 16, 2011
First Posted Date  ICMJE August 17, 2011
Last Update Posted Date December 11, 2012
Study Start Date  ICMJE September 2011
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 16, 2011)
Serum-vitamin D [ Time Frame: 12 weeks after treatment start ]
Levels of serum vitamin D3 and Serum -parathyroid hormone(PTH) are to be measured
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 25, 2012)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 16, 2011)
Muscle strengths in hands and legs [ Time Frame: 12 weeks after start of treatment ]
Muscle streght in hand is meassured with JAMAR dynamometer. Muscle straght in loweer legs is meassured with Balance test by Ekdahl. Quality of life questionaries will also be used.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vitamin Deficiency in Immigrants, a Treatment Study
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Vitamin D Deficiency
Intervention  ICMJE
  • 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
  • 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
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Group 1
    Vitamin D3, 10 000 IU daily. Treatment to patients with Serum-vitamin D levels below 25 nmol/L
    Intervention: Drug: Cholecalciferol
  • 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
    Intervention: Drug: Cholecalciferol
  • 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
    Intervention: Drug: Cholecalciferol
  • 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
    Intervention: Drug: Cholecalciferol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 10, 2012)
160
Original Estimated Enrollment  ICMJE
 (submitted: August 16, 2011)
150
Actual Study Completion Date  ICMJE October 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01419119
Other Study ID Numbers  ICMJE VIDI 2
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Margareta Norberg, Umeå University
Study Sponsor  ICMJE Umeå University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Margareta Norberg, M.D. Ph.D Dept of Epidemiology and Global Health, Umeå University
PRS Account Umeå University
Verification Date December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP