Vitamin D deficiency among Immigrants from Africa and Middle East in Northern Sweden

Project description

The overall aims of this project are to describe the levels of D-vitamin and the determinants of D-vitamin deficiency among immigrants from Africa and Middle East who live in Northern Sweden, and also to evaluate the effect of treatment of low D-vitamin levels with different pharmacological regimens. Data are collected in a population based cross-sectional study and an open randomized clinical trial.

The starting point for his project were clinical observations during 2006-2007 made by the head of this research during her work as GP in primary care at Ersboda Health Care Centre in Umeå, Northern Sweden. A remarkably large proportion of patients with origin from Africa or Middle East presented with complaints of fatigue and muscular weakness and pain. The prevalence of similar symptoms was so high that it seemed to be a public health problem within the immigrant population. At that time point, health care in Sweden did not pay much attention to D-vitamin deficiency, that was mainly considered to be a clinical problem among elderly with osteoporosis who live in institutions. It was at that time not possible to analyse D-vitamin at the University Hospital in Umeå, samples for analyses were sent to Uppsala. An evaluation of D-vitamin levels among these patients showed that the levels were remarkably low. In addition, at that time there were no clinical guidelines on in what clinical situation or how to evaluate D-vitamin levels or how to treat D-vitamin deficiency or D-vitamin insufficiency. Moreover, no pharmaceutical products for general prescription with sufficiently high doses for effective treatment of very low levels of D-vitamin were available for general prescription.

The population based cross-sectional study, VIDI 1, was performed Sept 2009-June 2010 at the Clinical Research Centre, Umeå University hospital. A total of 216 adult immigrants from Africa or Middle East participated. D-vitamin and PTH levels were analysed. Depression, balance and muscular strength were evaluated with validated questionnaires, and participants answered questionnaires on socio-economic status, muscular and depressive symptoms. Life style habits were included regarding covering cloths, nutritional intake with focus on fatty fish and milk products (D-vitamin rich food), and intake of D-vitamin supplementations. Preliminary results (May 2012) show that the D-vitamin levels generally are low, without difference between sexes, in this immigrant population in Northern Sweden. The prevalence of D-vitamin deficiency is high but life style factors are more important determinants for D-vitamin deficiency than native country, sex and age. Regional Ethical Board No 08-205M.

A randomized clinical trial, VIDI 2, was also initiated, planned and performed by the project members. This study followed principles for Good Clinical Practice and ICH guidelines for pharmaceutical phase IV studies. We invited those participants from VIDI 1, who were still living in the area, and additionally, other adults aged 25-65 years, originating from Africa or Middle East, until the expected numbers of participants was recruited. Data from VIDI 1 was used as a basis for power calculations. Participants were included in three groups: subjects with (i) D-vitamin deficiency, (ii) D-vitamin insufficiency, and (iii) suboptimal D-vitamin levels. Subjects with D-vitamin insufficiency were also randomly assigned to two groups for treatment with different doses of D-vitamin, where the lower dose corresponds to the recommended daily intake of D-vitamin in Sweden according to the National Food Agency. The pharmaceutical product allowed treatment with high doses of D-vitamin, it was approved by the MPA for general prescription but was not available before the study start. A pharmaceutical company donated the pharmaceutical product to the study and delivered it via Apoteket Farmaci, that labelled the product. This company did not take part in the planning, performance or evaluation of the study. The doses given in the study were chosen based on available international literature and were open for participants and the research group. Data collection was done September 2011-June 2012 at the Clinical Research Centre, Umeå University Hospital and the same trained research nurse as in VIDI 1 performed examinations and structured interviews. A physician, one of the project members, also took part in screening visits and inclusion/exclusion in the study. Monitoring was done by the Clinical Trial Unit, Västerbotten County Council. Analysis of data is on-going (May 2012). Regional Ethical Board No 2010-338-31M, ClinicalTrials.gov Identifier NCT01419119, EudraCT No 2010-024460-18, Medical Products Agency No 151:2011/48597.

The results of this study are expected to contribute to increased awareness of D-vitamin deficiency as a clinical problem among immigrants from Africa and Middle East who live in Northern Sweden. Results will also contribute to establishment of recommendations for preventive intake of D-vitamin supplements for self care, and also to clinical guidelines regarding evaluation and treatment of D-vitamin deficiency