Influence of Vitamin D Treatment on Multi-systemic Functions in Young Men With Vitamin D Deficiency Due to Work Conditions
Primary Purpose
Vitamin D Deficiency
Status
Completed
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Vitamin D
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Vitamin D Deficiency focused on measuring Quality of life
Eligibility Criteria
Inclusion Criteria:
- Healthy men between 20-65 years old
- For stage 2: baseline 25(OH)D levels < 20 ng/ml
Exclusion Criteria:
- 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
Sites / Locations
- Rambam health care campus
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
vitamin D
placebo
Arm Description
Outcomes
Primary Outcome Measures
Serum level of 25(OH)D
Secondary Outcome Measures
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
Full Information
NCT ID
NCT01016184
First Posted
November 18, 2009
Last Updated
January 30, 2013
Sponsor
Rambam Health Care Campus
1. Study Identification
Unique Protocol Identification Number
NCT01016184
Brief Title
Influence of Vitamin D Treatment on Multi-systemic Functions in Young Men With Vitamin D Deficiency Due to Work Conditions
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rambam Health Care Campus
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
The study has 2 stages: first stage would be survey of 400 employees, who will fill out a questionnaire to identify occupational and demographic risk factors, a nutritional questionnaire, and data from periodic checkups will be collected. Participants will sign a consent form for vitamin D level determinations, and for freezing blood samples. From this survey, the participants that have vitamin D deficiency (25(OH)D levels < 20 ng/ml) will continue to the second stage of the study - administration of vitamin D or placebo. Participants in the interventional study will sign an additional consent form. Length of follow-up: one year. All parameters will be tested at 0, 6, and 12 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency
Keywords
Quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
358 (Actual)
8. Arms, Groups, and Interventions
Arm Title
vitamin D
Arm Type
Active Comparator
Arm Title
placebo
Arm Type
Active Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D
Intervention Description
Oral vitamin D 100,000 IU
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Serum level of 25(OH)D
Time Frame
12 months
Secondary Outcome Measure Information:
Title
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
Time Frame
12 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy men between 20-65 years old
For stage 2: baseline 25(OH)D levels < 20 ng/ml
Exclusion Criteria:
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
Facility Information:
Facility Name
Rambam health care campus
City
Haifa
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Influence of Vitamin D Treatment on Multi-systemic Functions in Young Men With Vitamin D Deficiency Due to Work Conditions
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