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Vitamin D Status in Males in Jerusalem Area and Its Correlation to Parathyroid Hormone (PTH) Level and Bone Mineral Density

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Clalit Health Services.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Clalit Health Services
ClinicalTrials.gov Identifier:
NCT01025128
First received: December 1, 2009
Last updated: June 27, 2011
Last verified: December 2009
History of Changes
  Purpose

Because of its high sun exposure, Israel was traditionally supposed to be protected from vitamin D deficiency, and the country food products hardly contain vitamin D supplements. However the Jerusalem ultra-Orthodox population, which constitutes a significant fraction of the city population, is at risk of developing vitamin D deficiency due to low sun exposure, as consequence of its dressing code covering most of the body and very limited time of outside activities. The investigators aim is to check whether vitamin D deficiency is found more frequently in the ultra-Orthodox male population in comparison to a non-ultra-Orthodox male population, and to study its eventual consequences. Correlation between vitamin D levels and PTH levels will be examined, according to age and to creatinine levels. Bone mineral density (BMD) will be evaluated in 2 selected subgroups of subjects (with lowest and highest vitamin D levels), and re-evaluated after 6 months of vitamin D supplementation in vitamin D-deficient subjects. An increase in BMD within 6 months would suggest osteomalacia as the main cause of low BMD in these subjects.


Condition Intervention Phase
Vitamin D Deficiency
Secondary Hyperparathyroidism
Osteomalacia
 Drug: 25 OH vitamin D
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening

Resource links provided by NLM:

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

Further study details as provided by Clalit Health Services:

Primary Outcome Measures:
  • plasma vitamin D level [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • bone mineral density before vitamin D supplementation [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • plasma PTH level [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • bone mineral density after vitamin D supplementation in vitamin D deficient subjects [ Time Frame: 13 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: January 2010
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: group A low D
ultra-Orthodox clinics patients aged 18-39 with lowest vitamin D levels
 Drug: 25 OH vitamin D
oral supplementation of 25 OH vitamin D at dose of 2000 units/d for 3 months then 1000 units/d for 3 months
No Intervention: group A high D
ultra-Orthodox clinics patients aged 18-39 with highest vitamin D levels
Active Comparator: group B low D
mixed population clinics patients aged 18-39 with lowest vitamin D levels
 Drug: 25 OH vitamin D
oral supplementation of 25 OH vitamin D at dose of 2000 units/d for 3 months then 1000 units/d for 3 months
No Intervention: group B high D
mixed population clinics patients aged 18-39 with highest vitamin D levels

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male subjects aged 18-70
  • If age below 40 must not be under any chronic medication

Exclusion Criteria:

  • Medication: anti-convulsivants, non-topical steroids (past or present), anti-rejection medications
  • Malabsorptive diseases (Crohn's disease, cystic fibrosis,Whipple' disease, s/p bariatric surgery)
  • Morbid obesity (BMI above 35)
  • Rheumatoid arthritis
  • Liver failure
  • Nephrotic syndrome
  • Chronic kidney disease
  • Genetic disorder
  • Malignancy
  • Primary hyperparathyroidism
  • Granulomatous disease
  • Hyperthyroidism
  • Nephrolithiasis (present or past)
  • S/P skin grafts surgery
  • Mental disorder or cognitive disorder
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01025128

Contacts
Contact: Anat Tsur, MD +972522535475
Contact: Muriel Metzger, MD +972547445443 murielm2@012.net.il

Locations
Israel
Endocrinology Clinic, Clalit Health Services Recruiting
Jerusalem., Israel
Contact: Muriel Metzger, MD     +972547445443     murielm2@012.net.il    
Contact: Anat Tsur, MD     +972522535475        
Principal Investigator: Muriel Metzger, MD            
Principal Investigator: Anat Tsur, MD            
Sponsors and Collaborators
Clalit Health Services
Investigators
Principal Investigator: Muriel Metzger, MD Clalit Health Services, Jerusalem, Israel
Principal Investigator: Anat Tsur, MD Clalit Health Services, Jerusalem, Israel
  More Information

No publications provided

Responsible Party: Muriel Metzger M.D. and Anat Tsur M.D., Clalit Health Services
ClinicalTrials.gov Identifier: NCT01025128     History of Changes
Other Study ID Numbers: K129/09
Study First Received: December 1, 2009
Last Updated: June 27, 2011
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Secondary
Osteomalacia
Vitamin D Deficiency
Parathyroid Diseases
Endocrine System Diseases
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Calcium Metabolism Disorders
Metabolic Diseases
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 May 23, 2013