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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
rambam56, Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01016184
First received: November 18, 2009
Last updated: January 30, 2013
Last verified: January 2013

November 18, 2009
January 30, 2013
September 2009
March 2012   (final data collection date for primary outcome measure)
Serum level of 25(OH)D [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01016184 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Vitamin D Deficiency
  • Dietary Supplement: Vitamin D
    Oral vitamin D 100,000 IU
  • Dietary Supplement: Placebo
    Placebo
  • Active Comparator: vitamin D
    Intervention: Dietary Supplement: Vitamin D
  • Active Comparator: placebo
    Intervention: Dietary Supplement: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
358
March 2012
March 2012   (final data collection date for primary outcome measure)

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
Male
25 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT01016184
odds3153
No
rambam56, Rambam Health Care Campus
Rambam Health Care Campus
Not Provided
Not Provided
Rambam Health Care Campus
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP