Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
160 participants
INTERVENTIONAL
2011-09-30
2012-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group 1
Vitamin D3, 10 000 IU daily. Treatment to patients with Serum-vitamin D levels below 25 nmol/L
Cholecalciferol high dose at Vitamin D deficiency
10 000 IU daily i.e. 15 drops orally once daily for 12 weeks
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
Cholecalciferol median dose at Vitamin D insufficiency
2000 IU daily i.e. 3 drops orally once a day for 12 weeks,
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
Cholecalciferol low dose at Vitamin D deficiency
2000 IU once a week i.e. 3 drops orally once a week (the same day every week) for 12 weeks,
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
Cholecalciferol median dose at sufficient Vitamin D level
2000 IU daily i.e. 3 drops orally once daily for 12 weeks
Interventions
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Cholecalciferol high dose at Vitamin D deficiency
10 000 IU daily i.e. 15 drops orally once daily for 12 weeks
Cholecalciferol median dose at Vitamin D insufficiency
2000 IU daily i.e. 3 drops orally once a day for 12 weeks,
Cholecalciferol low dose at Vitamin D deficiency
2000 IU once a week i.e. 3 drops orally once a week (the same day every week) for 12 weeks,
Cholecalciferol median dose at sufficient Vitamin D level
2000 IU daily i.e. 3 drops orally once daily for 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Men and female
* 25-65 years of age
* Born in Middle East or Africa, living in Umeå district
Exclusion Criteria
* 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
25 Years
65 Years
ALL
No
Sponsors
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Umeå University
OTHER
Responsible Party
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Margareta Norberg
M.D. Ph.D.
Principal Investigators
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Margareta Norberg, M.D. Ph.D
Role: PRINCIPAL_INVESTIGATOR
Dept of Epidemiology and Global Health, Umeå University
Locations
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Ålidhems hälsocentral, Umeå
Umeå, , Sweden
Countries
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Other Identifiers
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VIDI 2
Identifier Type: -
Identifier Source: org_study_id
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