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Influence of Vitamin D Treatment on Multi-systemic Functions in Young Men With Vitamin D Deficiency Due to Work Conditions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01016184
Recruitment Status : Completed
First Posted : November 19, 2009
Last Update Posted : February 1, 2013
Information provided by (Responsible Party):
rambam56, Rambam Health Care Campus

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.

Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Dietary Supplement: Vitamin D Dietary Supplement: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 358 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : September 2009
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Arm Intervention/treatment
Active Comparator: vitamin D Dietary Supplement: Vitamin D
Oral vitamin D 100,000 IU

Active Comparator: placebo Dietary Supplement: Placebo

Primary Outcome Measures :
  1. Serum level of 25(OH)D [ Time Frame: 12 months ]

Secondary Outcome Measures :
  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 [ Time Frame: 12 months ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01016184

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Rambam health care campus
Haifa, Israel
Sponsors and Collaborators
Rambam Health Care Campus
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Responsible Party: rambam56, head of metabolic bone disease unit, Rambam Health Care Campus Identifier: NCT01016184    
Other Study ID Numbers: odds3153
First Posted: November 19, 2009    Key Record Dates
Last Update Posted: February 1, 2013
Last Verified: January 2013
Keywords provided by rambam56, Rambam Health Care Campus:
Quality of life
Additional relevant MeSH terms:
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Vitamin D Deficiency
Deficiency Diseases
Nutrition Disorders
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents