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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
History of Changes
  Purpose

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 Intervention Phase
Vitamin D Deficiency
 Dietary Supplement: Vitamin D
Dietary Supplement: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

Drug Information available for: Vitamin D
U.S. FDA Resources

Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • Serum level of 25(OH)D [ Time Frame: 12 months ] [ Designated as safety issue: No ]

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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 358
Study Start Date: September 2009
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: vitamin D Dietary Supplement: Vitamin D
Oral vitamin D 100,000 IU
Active Comparator: placebo Dietary Supplement: Placebo
Placebo

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.

  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01016184

Locations
Israel
Rambam health care campus
Haifa, Israel
Sponsors and Collaborators
Rambam Health Care Campus
  More Information

No publications provided

Responsible Party: rambam56, head of metabolic bone disease unit, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01016184     History of Changes
Other Study ID Numbers: odds3153
Study First Received: November 18, 2009
Last Updated: January 30, 2013
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Rambam Health Care Campus:
Quality of life

Additional relevant MeSH terms:
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Ergocalciferols
 Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on June 17, 2013