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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014