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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
Rambam Health Care Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitamin D Deficiency focused on measuring Quality of life

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

First Posted
November 18, 2009
Last Updated
January 30, 2013
Sponsor
Rambam Health Care Campus
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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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