Vitamin Deficiency Clinical Trial
Official title:
Effect of Vitamin D Supplementation on Muscular Strength, Musculoskeletal Pain and Headache in Immigrants Living in Norway. Randomized, Double Blinded, Placebo Controlled Study
The primary aim of the present trial is to study the effect of daily vitamin D
supplementation on muscular power and force among non-western immigrants living in Oslo,
Norway, and secondarily to study the effect of musculoskeletal pain and headache.
The investigators have also prespecified a number of additional research questions about
anemia, metabolism and bone turnover, inflammation, diabetes, lipids, itching and kidney
function, which because of multiple comparisons should be interpreted with caution unless
the statistical evidence for an effect is very strong.
Vitamin D deficiency is a widespread public health problem among immigrants from non-Western
countries in Norway. As a background for preventive strategies it is important to have best
possible knowledge about health consequences of poor vitamin D status, and in this respect
much is lacking.
The investigators will aim to study the effect of vitamin D supplementation on muscular
strength , musculoskeletal pain and headache among non-western immigrants in Norway with
background from Middle East, Africa and South Asia. In addition the intervention gives us
the opportunity to study the effect of vitamin D on indicators of other important health
issues including anemia, diabetes , lipids, inflammation, metabolism and bone health. The
study will also contribute with insight on how to achieve a high compliance. This is of
interest in a broader context as poor compliance has been experienced as a problem in
primary health care among immigrants with poor vitamin D status.
The study is a randomized, double blinded, placebo-controlled trial which compares two doses
of vitamin D supplements, 400 IU and 1000 IU, with placebo and the tablets will be taken
daily in a period of 4 months. Three muscle strength tests will be used, and they will be
performed before and after the intervention: Counter movement jumps, Chair rising and
Handgrip. Level and location of musculoskeletal pain and headache will be recorded at
baseline and at end of the study.
A blood sample will be collected from the study subjects at baseline and after 4 months. The
level of vitamin D and markers of anemia, metabolism and bone turnover, inflammation,
diabetes, lipids and kidney function will be measured.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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