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Vitamin Deficiency in Immigrants, a Treatment Study (VIDI2)

Primary Purpose

Vitamin D Deficiency

Status
Completed
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
Cholecalciferol
Cholecalciferol
Cholecalciferol
Cholecalciferol
Sponsored by
Umeå University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitamin D Deficiency focused on measuring vitamin D insufficiency, Cholecalciferol, D3, Parathyroid Hormone, 25-hydroxyvitamin D3, RDA, recommended daily intake (nutrition policy), Vitamin D, Hypovitaminosis-D, Pharmacologic treatment

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ålidhems hälsocentral, Umeå

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Group 1

Group 2a

Group 2b

Group 3

Arm Description

Vitamin D3, 10 000 IU daily. Treatment to patients with Serum-vitamin D levels below 25 nmol/L

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

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

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

Outcomes

Primary Outcome Measures

Serum-vitamin D
Levels of serum vitamin D3 and Serum -parathyroid hormone(PTH) are to be measured

Secondary Outcome Measures

Muscle strengths in hands and legs
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.

Full Information

First Posted
August 16, 2011
Last Updated
December 10, 2012
Sponsor
Umeå University
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1. Study Identification

Unique Protocol Identification Number
NCT01419119
Brief Title
Vitamin Deficiency in Immigrants, a Treatment Study
Acronym
VIDI2
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 Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Umeå University

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
Vitamin D3, 10 000 IU daily. Treatment to patients with Serum-vitamin D levels below 25 nmol/L
Arm Title
Group 2a
Arm Type
Experimental
Arm Description
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
Arm Title
Group 2b
Arm Type
Experimental
Arm Description
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
Arm Title
Group 3
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Cholecalciferol
Other Intervention Name(s)
Vigantol Oil 20 000 IU/ml, drops for oral use, solution
Intervention Description
10 000 IU daily i.e. 15 drops orally once daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Cholecalciferol
Other Intervention Name(s)
Vigantol Oil 20 000 IU/ml, drops for oral use, solution
Intervention Description
2000 IU daily i.e. 3 drops orally once a day for 12 weeks,
Intervention Type
Drug
Intervention Name(s)
Cholecalciferol
Other Intervention Name(s)
Vigantol Oil 20 000 IU/ml, drops for oral use, solution
Intervention Description
2000 IU once a week i.e. 3 drops orally once a week (the same day every week) for 12 weeks,
Intervention Type
Drug
Intervention Name(s)
Cholecalciferol
Other Intervention Name(s)
Vigantol Oil 20 000 IU/ml, drops for oral use, solution
Intervention Description
2000 IU daily i.e. 3 drops orally once daily for 12 weeks
Primary Outcome Measure Information:
Title
Serum-vitamin D
Description
Levels of serum vitamin D3 and Serum -parathyroid hormone(PTH) are to be measured
Time Frame
12 weeks after treatment start
Secondary Outcome Measure Information:
Title
Muscle strengths in hands and legs
Description
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.
Time Frame
12 weeks after start of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margareta Norberg, M.D. Ph.D
Organizational Affiliation
Dept of Epidemiology and Global Health, Umeå University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ålidhems hälsocentral, Umeå
City
Umeå
ZIP/Postal Code
Se-90736
Country
Sweden

12. IPD Sharing Statement

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Vitamin Deficiency in Immigrants, a Treatment Study

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