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

June 21, 2013 updated by: Per Lagerlov

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

251

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0318
        • University of Oslo, Institute of Health and Society

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Dietary supplement: Placebo
Microcrystalline cellulose tablet p.o.daily. (Same color, shape and size as vitamin D tablet)
Other Names:
  • NN009
ACTIVE_COMPARATOR: Vitamin D3 (cholecalciferol) 400 IU
Dietary supplement: cholecalciferol
Vitamin D3 tablet 400 IU. Once daily by mouth for 4 months
Other Names:
  • NN007
Dietary supplement: cholecalciferol
Vitamin D3 tablet 1000 IU. Once daily by mouth for 4 months
Other Names:
  • NN008
ACTIVE_COMPARATOR: Vitamin D3 (cholecalciferol) 1000 IU
Dietary supplement: cholecalciferol
Vitamin D3 tablet 400 IU. Once daily by mouth for 4 months
Other Names:
  • NN007
Dietary supplement: cholecalciferol
Vitamin D3 tablet 1000 IU. Once daily by mouth for 4 months
Other Names:
  • NN008

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Muscular strength: jump height
Time Frame: 4 months
4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Musculoskeletal pain, headache, muscular strength; chair rising and handgrip
Time Frame: 4 months
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Per Lagerlov

Collaborators

Norwegian Institute of Public Health
Norwegian School of Sport Sciences

Investigators

  • Study Chair: Per Lagerlov, MD, PhD, University of Oslo
  • Study Chair: Haakon E Meyer, Professor, University of Oslo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (ACTUAL)

April 1, 2012

Study Completion (ACTUAL)

January 1, 2013

Study Registration Dates

First Submitted

December 17, 2010

First Submitted That Met QC Criteria

December 17, 2010

First Posted (ESTIMATE)

December 20, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

June 24, 2013

Last Update Submitted That Met QC Criteria

June 21, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-1982

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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