Influence of Vitamin D Treatment on Multi-systemic Functions in Young Men With Vitamin D Deficiency Due to Work Conditions
Prospective, Randomized, Double Blind Placebo Controled Clinical Trial to Assess the Multi- Systemic Effect of Vitamin D Supplementation on Young Men With Vitamin D Deficiency
1 other identifier
interventional
358
1 country
1
Brief Summary
Vitamin D has multiple systemic effects: bone and calcium metabolism, muscle function, insulin responsiveness, body-composition regulation, cell differentiation, and the immune system. Proper status of vitamin D is found to be related to risk reduction in hypertension, cardiac and vascular diseases, autoimmune diseases, and others. Furthermore, vitamin D supplementation resulted in improved endothelial function. Limited sun exposure may lead to vitamin D deficiency, and it may be assumed that modern life styles lead to a lack of sun exposure. Long work-days may be the primary risk factor for vitamin D deficiency. The purpose of this research is to study the effect of vitamin D treatment on multi systemic functions in young healthy men with vitamin D deficiency due to working conditions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2009
Typical duration for phase_4
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
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 18, 2009
CompletedFirst Posted
Study publicly available on registry
November 19, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedFebruary 1, 2013
January 1, 2013
2.5 years
November 18, 2009
January 30, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Serum level of 25(OH)D
12 months
Secondary Outcomes (1)
Blood pressure, Endothelial function, Muscle strength. Quality of life, absence from work Laboratory measures:PTH, P1NP, β-CTx, Inflammation markers (hs-CRP), Fasting glucose levels, Insulin, Lipids profile
12 months
Study Arms (2)
vitamin D
ACTIVE COMPARATORplacebo
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Healthy men between 20-65 years old
- For stage 2: baseline 25(OH)D levels \< 20 ng/ml
You may not qualify if:
- Liver dysfunction
- Kidney dysfunction
- Patients with unbalanced chronic diseases
- Regular use of medications that lower serum vitamin D levels, or which interfere with intestinal vitamin D absorption
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rambam health care campus
Haifa, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- head of metabolic bone disease unit
Study Record Dates
First Submitted
November 18, 2009
First Posted
November 19, 2009
Study Start
September 1, 2009
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
February 1, 2013
Record last verified: 2013-01