Effect of Vitamin D Supplementation on Muscular Strength, Musculoskeletal Pain and Headache

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01263288
• Other study ID #: 2010-1982
• Status: Completed
• Phase: Phase 4
• First received: December 17, 2010
• Last updated: June 21, 2013
• Start date: January 2011
• Est. completion date: January 2013

Study information

• Verified date: June 2013
• Source: University of Oslo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research EthicsNorway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 251
• Est. completion date: January 2013
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Avitaminosis
• Musculoskeletal Pain
• Vitamin Deficiency

Intervention

Dietary Supplement:
• cholecalciferol
Vitamin D3 tablet 400 IU. Once daily by mouth for 4 months
• cholecalciferol
Vitamin D3 tablet 1000 IU. Once daily by mouth for 4 months
• Placebo
Microcrystalline cellulose tablet p.o.daily. (Same color, shape and size as vitamin D tablet)

Locations

Country	Name	City	State
Norway	University of Oslo, Institute of Health and Society	Oslo

Sponsors (3)

Lead Sponsor	Collaborator
Per Lagerlov	Norwegian Institute of Public Health, Norwegian School of Sport Sciences

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Knutsen KV, Brekke M, Gjelstad S, Lagerløv 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscular strength: jump height		4 months	No
Secondary	Musculoskeletal pain, headache, muscular strength; chair rising and handgrip		4 months	No