Phase 4 N=160 Randomized Treatment

Vitamin Deficiency in Immigrants, a Treatment Study

Vitamin D Deficiency

Bottom Line

View on ClinicalTrials.gov: NCT01419119 ↗

Enrolled (actual)

160

Serious AEs

0.6%

Results posted

Jul 2024

Primary outcome: Primary: Serum-vitamin D — 19.7; 34.4; 38.7; 58.7 25(OH)D, nmol/L — p=0.001

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Cholecalciferol high dose at Vitamin D deficiency (Drug); Cholecalciferol median dose at Vitamin D insufficiency (Drug); Cholecalciferol low dose at Vitamin D deficiency (Drug); Cholecalciferol median dose at sufficient Vitamin D level (Drug)
Age: Adult, Older Adult · 25+ yrs
Sex: All
Sponsor: Umeå University
Primary completion: Oct 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Serum-vitamin D	19.7; 34.4; 38.7; 58.7	0.001 sig
PRIMARY Level of Vitamin D at End of the Treatment Period of 12 Weeks	140.8; 72.5; 52.3; 81.0	0.001 sig

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01419119). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.