Effect of Vitamin D Supplementation on Muscular Strength, Musculoskeletal Pain and Headache
Primary Purpose
Vitamin Deficiency
Status
Completed
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
cholecalciferol
cholecalciferol
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Vitamin Deficiency
Eligibility Criteria
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
Sites / Locations
- University of Oslo, Institute of Health and Society
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Vitamin D3 (cholecalciferol) 400 IU
Vitamin D3 (cholecalciferol) 1000 IU
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Muscular strength: jump height
Secondary Outcome Measures
Musculoskeletal pain, headache, muscular strength; chair rising and handgrip
Full Information
NCT ID
NCT01263288
First Posted
December 17, 2010
Last Updated
June 21, 2013
Sponsor
Per Lagerlov
Collaborators
Norwegian School of Sport Sciences, Norwegian Institute of Public Health
1. Study Identification
Unique Protocol Identification Number
NCT01263288
Brief Title
Effect of Vitamin D Supplementation on Muscular Strength, Musculoskeletal Pain and Headache
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Per Lagerlov
Collaborators
Norwegian School of Sport Sciences, Norwegian Institute of Public Health
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin Deficiency
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
251 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vitamin D3 (cholecalciferol) 400 IU
Arm Type
Active Comparator
Arm Title
Vitamin D3 (cholecalciferol) 1000 IU
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
cholecalciferol
Other Intervention Name(s)
NN007
Intervention Description
Vitamin D3 tablet 400 IU. Once daily by mouth for 4 months
Intervention Type
Dietary Supplement
Intervention Name(s)
cholecalciferol
Other Intervention Name(s)
NN008
Intervention Description
Vitamin D3 tablet 1000 IU. Once daily by mouth for 4 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Other Intervention Name(s)
NN009
Intervention Description
Microcrystalline cellulose tablet p.o.daily. (Same color, shape and size as vitamin D tablet)
Primary Outcome Measure Information:
Title
Muscular strength: jump height
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Musculoskeletal pain, headache, muscular strength; chair rising and handgrip
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per Lagerlov, MD, PhD
Organizational Affiliation
University of Oslo
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Haakon E Meyer, Professor
Organizational Affiliation
University of Oslo
Official's Role
Study Chair
Facility Information:
Facility Name
University of Oslo, Institute of Health and Society
City
Oslo
ZIP/Postal Code
0318
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
20642395
Citation
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.
Results Reference
background
PubMed Identifier
28377958
Citation
Madar 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.
Results Reference
derived
PubMed Identifier
25452867
Citation
Madar 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.
Results Reference
derived
PubMed Identifier
24248184
Citation
Knutsen 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.
Results Reference
derived
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Effect of Vitamin D Supplementation on Muscular Strength, Musculoskeletal Pain and Headache
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