Ignite Creation Date:
2024-05-05 @ 11:08 PM
Last Modification Date:
2024-10-26 @ 10:29 AM
Study NCT ID:
NCT01263288
Status:
COMPLETED
Last Update Posted:
2013-06-24
First Post:
2010-12-17
Brief Title:
Effect of Vitamin D Supplementation on Muscular Strength Musculoskeletal Pain and Headache
Sponsor:
Per Lagerlov
Organization:
University of Oslo
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None