Vitamin DeficiencyPhase 4NCT01263288
Effect of Vitamin D Supplementation on Muscular Strength, Musculoskeletal Pain and Headache
A Phase 4 study testing cholecalciferol in people with Vitamin Deficiency, run by Per Lagerlov at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin Deficiency
- What is being tested?
- cholecalciferol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 251 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2011to Jan 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female between 18 - 50 years old
- Immigrants with background from Middle East, Africa and South Asia.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Norway1 site
University of Oslo, Institute of Health and Society
Oslo, Oslo, 0318
About this study
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
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.
Read the 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.
- Conditions
- Vitamin Deficiency
- Being tested
- cholecalciferol, Placebo
- Medical subject headings
- Avitaminosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cholecalciferolDietary supplement
Also called NN007
Vitamin D3 tablet 400 IU. Once daily by mouth for 4 months
cholecalciferolDietary supplement
Also called NN008
Vitamin D3 tablet 1000 IU. Once daily by mouth for 4 months
PlaceboDietary supplement
Also called NN009
Microcrystalline cellulose tablet p.o.daily. (Same color, shape and size as vitamin D tablet)
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D3 (cholecalciferol) 400 IU | Active comparator | Not described Receives: Dietary Supplement: cholecalciferol |
| Vitamin D3 (cholecalciferol) 1000 IU | Active comparator | Not described Receives: Dietary Supplement: cholecalciferol |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscular strength: jump height
Measured: 4 months
Secondary outcomes (1)
Musculoskeletal pain, headache, muscular strength; chair rising and handgrip
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2010 (estimated)
- Study startJan 2011
- Primary completionApr 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Vitamin DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 251 participants (actual)
Sponsor and investigators
- Lead sponsor
- Per Lagerlov
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian School of Sport Sciences, Norwegian Institute of Public Health
- Responsible party
- Sponsor-investigator, Per Lagerlov, University of Oslo
- Investigators
- Per Lagerlov, MD, PhD, Study chair, University of OsloHaakon E Meyer, Professor, Study chair, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01263288
- Sponsor's protocol ID
- 2010-1982
- Status last verified
- Jun 2013
- First submitted
- 17 Dec 2010
- Last updated
- 24 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20642395Madar 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.
PubMed 28377958Madar 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.
PubMed 25452867Knutsen 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.
PubMed 24248184
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01263288
- Acronym / sponsor ID
- 2010-1982
- Conditions
- Vitamin Deficiency
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 251 participants (actual)
- Lead sponsor
- Per LagerlovUniversity, hospital or other
- Collaborators
- Norwegian School of Sport Sciences, Norwegian Institute of Public Health
- Study start
- Jan 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 20 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vitamin D3 (cholecalciferol) 400 IU | Active comparator | Dietary Supplement: cholecalciferol |
| Vitamin D3 (cholecalciferol) 1000 IU | Active comparator | Dietary Supplement: cholecalciferol |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Male and female between 18 - 50 years old
- Immigrants with background from Middle East, Africa and South Asia.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cholecalciferolAlso: NN007Vitamin D3 tablet 400 IU. Once daily by mouth for 4 months | Dietary supplement | Vitamin D3 (cholecalciferol) 400 IU |
| cholecalciferolAlso: NN008Vitamin D3 tablet 1000 IU. Once daily by mouth for 4 months | Dietary supplement | Vitamin D3 (cholecalciferol) 1000 IU |
| PlaceboAlso: NN009Microcrystalline cellulose tablet p.o.daily. (Same color, shape and size as vitamin D tablet) | Dietary supplement | Placebo |
Primary outcome
Muscular strength: jump height
Time frame: 4 months
1 secondary outcome
Musculoskeletal pain, headache, muscular strength; chair rising and handgrip
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2013.
- Background: PubMed 20642395Knutsen 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.
- Derived from this study: PubMed 28377958Madar 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.
- Derived from this study: PubMed 25452867Madar 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.
- Derived from this study: PubMed 24248184Knutsen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per Lagerlov, MD, PhD study chair
University of Oslo
Haakon E Meyer, Professor study chair
University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing cholecalciferol in people with Vitamin Deficiency, run by Per Lagerlov at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscular strength: jump height (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01263288, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2013.