Clinical trial NCT01263288: Effect of Vitamin D Supplementation on Muscular Strength, Musculoskeletal Pain and Headache
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vitamin Deficiency
Lead sponsor: University of Oslo
Sponsor class: OTHER
Collaborators: name: Norwegian School of Sport Sciences
name: Norwegian Institute of Public Health
First posted: 2010-12-20
Enrollment: 251
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Male and female between 18 - 50 years old
* Immigrants with background from Middle East, Africa and South Asia.

Exclusion Criteria:

* Daily use of vitamin D supplementation and frequently use of artificial UV light exposure.
* Pregnancy
* Malabsorptive disorders
* Fracture in the leg /arm within the preceding 6 months. Known osteoporosis
* Tuberculosis, sarcoidosis, cancer, kidney dysfunction, liver dysfunction and history of kidney stone.
* Regular use of medication that interfere with vitamin D/bone metabolism, such as glucocorticoids, diuretics, lithium, antiepileptics, bisphosphonates,
* Regular use of strong pain killers.
* Medication for diabetes

Primary outcomes:
measure: Muscular strength: jump height
timeFrame: 4 months
Secondary outcomes:
measure: Musculoskeletal pain, headache, muscular strength; chair rising and handgrip
timeFrame: 4 months
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: University of Oslo, Institute of Health and Society
Study officials:
affiliation: University of Oslo
name: Per Lagerlov, MD, PhD
role: STUDY_CHAIR
affiliation: University of Oslo
name: Haakon E Meyer, Professor
role: STUDY_CHAIR
References:
citation: Knutsen KV, Brekke M, Gjelstad S, Lagerlov P. Vitamin D status in patients with musculoskeletal pain, fatigue and headache: a cross-sectional descriptive study in a multi-ethnic general practice in Norway. Scand J Prim Health Care. 2010 Sep;28(3):166-71. doi: 10.3109/02813432.2010.505407.
citation: Madar AA, Knutsen KV, Stene LC, Brekke M, Lagerlov P, Meyer HE, Macdonald HM. Effect of vitamin D3-supplementation on bone markers (serum P1NP and CTX): A randomized, double blinded, placebo controlled trial among healthy immigrants living in Norway. Bone Rep. 2015 May 21;2:82-88. doi: 10.1016/j.bonr.2015.05.004. eCollection 2015 Jun.
citation: Madar AA, Knutsen KV, Stene LC, Brekke M, Meyer HE, Lagerlov P. Effect of vitamin D3 supplementation on glycated hemoglobin (HbA1c), fructosamine, serum lipids, and body mass index: a randomized, double-blinded, placebo-controlled trial among healthy immigrants living in Norway. BMJ Open Diabetes Res Care. 2014 Oct 13;2(1):e000026. doi: 10.1136/bmjdrc-2014-000026. eCollection 2014.
citation: Knutsen KV, Madar AA, Lagerlov P, Brekke M, Raastad T, Stene LC, Meyer HE. Does vitamin D improve muscle strength in adults? A randomized, double-blind, placebo-controlled trial among ethnic minorities in Norway. J Clin Endocrinol Metab. 2014 Jan;99(1):194-202. doi: 10.1210/jc.2013-2647. Epub 2013 Dec 20.