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

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ClinicalTrials.gov Identifier: NCT01263288
Recruitment Status : Completed
First Posted : December 20, 2010
Last Update Posted : June 24, 2013
Sponsor:
Collaborators:
Norwegian School of Sport Sciences
Norwegian Institute of Public Health
Information provided by (Responsible Party):
Per Lagerlov, University of Oslo

Tracking Information
First Submitted Date  ICMJE December 17, 2010
First Posted Date  ICMJE December 20, 2010
Last Update Posted Date June 24, 2013
Study Start Date  ICMJE January 2011
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 17, 2010)
Muscular strength: jump height [ Time Frame: 4 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01263288 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 17, 2010)
Musculoskeletal pain, headache, muscular strength; chair rising and handgrip [ Time Frame: 4 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Vitamin D Supplementation on Muscular Strength, Musculoskeletal Pain and Headache
Official Title  ICMJE Effect of Vitamin D Supplementation on Muscular Strength, Musculoskeletal Pain and Headache in Immigrants Living in Norway. Randomized, Double Blinded, Placebo Controlled Study
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Vitamin Deficiency
Intervention  ICMJE
  • Dietary Supplement: cholecalciferol
    Vitamin D3 tablet 400 IU. Once daily by mouth for 4 months
    Other Name: NN007
  • Dietary Supplement: cholecalciferol
    Vitamin D3 tablet 1000 IU. Once daily by mouth for 4 months
    Other Name: NN008
  • Dietary Supplement: Placebo
    Microcrystalline cellulose tablet p.o.daily. (Same color, shape and size as vitamin D tablet)
    Other Name: NN009
Study Arms  ICMJE
  • Active Comparator: Vitamin D3 (cholecalciferol) 400 IU
    Intervention: Dietary Supplement: cholecalciferol
  • Active Comparator: Vitamin D3 (cholecalciferol) 1000 IU
    Intervention: Dietary Supplement: cholecalciferol
  • Placebo Comparator: Placebo
    Intervention: Dietary Supplement: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 28, 2013)
251
Original Estimated Enrollment  ICMJE
 (submitted: December 17, 2010)
300
Actual Study Completion Date  ICMJE January 2013
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01263288
Other Study ID Numbers  ICMJE 2010-1982
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Per Lagerlov, University of Oslo
Study Sponsor  ICMJE Per Lagerlov
Collaborators  ICMJE
  • Norwegian School of Sport Sciences
  • Norwegian Institute of Public Health
Investigators  ICMJE
Study Chair: Per Lagerlov, MD, PhD University of Oslo
Study Chair: Haakon E Meyer, Professor University of Oslo
PRS Account University of Oslo
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP