Effect of Vitamin D Supplementation on Muscular Strength, Musculoskeletal Pain and Headache
1 other identifier
interventional
251
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jan 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 17, 2010
CompletedFirst Posted
Study publicly available on registry
December 20, 2010
CompletedStudy Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedJune 24, 2013
June 1, 2013
1.2 years
December 17, 2010
June 21, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Muscular strength: jump height
4 months
Secondary Outcomes (1)
Musculoskeletal pain, headache, muscular strength; chair rising and handgrip
4 months
Study Arms (3)
Vitamin D3 (cholecalciferol) 400 IU
ACTIVE COMPARATORVitamin D3 (cholecalciferol) 1000 IU
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
Vitamin D3 tablet 400 IU. Once daily by mouth for 4 months
Microcrystalline cellulose tablet p.o.daily. (Same color, shape and size as vitamin D tablet)
Eligibility Criteria
You may qualify if:
- Male and female between 18 - 50 years old
- Immigrants with background from Middle East, Africa and South Asia.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Per Lagerlovlead
- Norwegian School of Sport Sciencescollaborator
- Norwegian Institute of Public Healthcollaborator
Study Sites (1)
University of Oslo, Institute of Health and Society
Oslo, Oslo County, 0318, Norway
Related Publications (4)
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.
PMID: 20642395BACKGROUNDMadar 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.
PMID: 28377958DERIVEDMadar 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.
PMID: 25452867DERIVEDKnutsen 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.
PMID: 24248184DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Per Lagerlov, MD, PhD
University of Oslo
- STUDY CHAIR
Haakon E Meyer, Professor
University of Oslo
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
December 17, 2010
First Posted
December 20, 2010
Study Start
January 1, 2011
Primary Completion
April 1, 2012
Study Completion
January 1, 2013
Last Updated
June 24, 2013
Record last verified: 2013-06