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Completed

NCT Number: NCT01263288

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

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Oslo, Institute of Health and Society

Oslo, 0318, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cholecalciferol

Dietary Supplement

Vitamin D3 tablet 400 IU. Once daily by mouth for 4 months

Other names: NN007

Placebo

Dietary Supplement

Microcrystalline cellulose tablet p.o.daily. (Same color, shape and size as vitamin D tablet)

Other names: NN009

Primary outcomes

  1. Muscular strength: jump height

    Time frame: 4 months

Secondary outcomes

  1. Musculoskeletal pain, headache, muscular strength; chair rising and handgrip

    Time frame: 4 months

Sponsors and collaborators

Lead sponsor

Per Lagerlov

Other

Collaborators

  • Norwegian Institute of Public Health
  • Norwegian School of Sport Sciences

Registry information

Official study title

Effect of Vitamin D Supplementation on Muscular Strength, Musculoskeletal Pain and Headache in Immigrants Living in Norway. Randomized, Double Blinded, Placebo Controlled Study

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Dec 20, 2010
Registry last updated
Jun 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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