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

This study has been completed.
Sponsor:
Collaborators:
Norwegian School of Sport Sciences
Norwegian Institute of Public Health
Information provided by (Responsible Party):
Per Lagerlov, University of Oslo
ClinicalTrials.gov Identifier:
NCT01263288
First received: December 17, 2010
Last updated: June 21, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Vitamin Deficiency
Dietary Supplement: cholecalciferol
Dietary Supplement: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by University of Oslo:

Primary Outcome Measures:
  • Muscular strength: jump height [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Musculoskeletal pain, headache, muscular strength; chair rising and handgrip [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Enrollment: 251
Study Start Date: January 2011
Study Completion Date: January 2013
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vitamin D3 (cholecalciferol) 400 IU Dietary Supplement: cholecalciferol
Vitamin D3 tablet 400 IU. Once daily by mouth for 4 months
Other Name: NN007
Active Comparator: Vitamin D3 (cholecalciferol) 1000 IU Dietary Supplement: cholecalciferol
Vitamin D3 tablet 1000 IU. Once daily by mouth for 4 months
Other Name: NN008
Placebo Comparator: Placebo Dietary Supplement: Placebo
Microcrystalline cellulose tablet p.o.daily. (Same color, shape and size as vitamin D tablet)
Other Name: NN009

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01263288

Locations
Norway
University of Oslo, Institute of Health and Society
Oslo, Norway, 0318
Sponsors and Collaborators
Per Lagerlov
Norwegian School of Sport Sciences
Norwegian Institute of Public Health
Investigators
Study Chair: Per Lagerlov, MD, PhD University of Oslo
Study Chair: Haakon E Meyer, Professor University of Oslo
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Per Lagerlov, Associate Professor, University of Oslo
ClinicalTrials.gov Identifier: NCT01263288     History of Changes
Other Study ID Numbers: 2010-1982
Study First Received: December 17, 2010
Last Updated: June 21, 2013
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Medicines Agency

Additional relevant MeSH terms:
Avitaminosis
Musculoskeletal Pain
Deficiency Diseases
Malnutrition
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neurologic Manifestations
Nutrition Disorders
Pain
Cholecalciferol
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 20, 2014