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

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ClinicalTrials.gov Identifier: NCT01025128
Recruitment Status : Completed
First Posted : December 3, 2009
Last Update Posted : July 21, 2014
Sponsor:
Information provided by (Responsible Party):
Metzger Muriel, Clalit Health Services

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Vitamin D Deficiency Secondary Hyperparathyroidism Osteomalacia Drug: 25 OH vitamin D Phase 4

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 210 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Study Start Date : January 2010
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Minerals Vitamin D
Drug Information available for: Vitamin D
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. plasma vitamin D level [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. bone mineral density before vitamin D supplementation [ Time Frame: 8 months ]
  2. plasma PTH level [ Time Frame: 6 months ]
  3. bone mineral density after vitamin D supplementation in vitamin D deficient subjects [ Time Frame: 13 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes 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
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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 ClinicalTrials.gov identifier (NCT number): NCT01025128


Locations
Israel
Endocrinology Clinic, Clalit Health Services
Jerusalem., Israel
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Metzger Muriel, MD, Clalit Health Services
ClinicalTrials.gov Identifier: NCT01025128     History of Changes
Other Study ID Numbers: K129/09
First Posted: December 3, 2009    Key Record Dates
Last Update Posted: July 21, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
Vitamin D Deficiency
Hyperparathyroidism
Hyperparathyroidism, Secondary
Osteomalacia
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Parathyroid Diseases
Endocrine System Diseases
Rickets
Bone Diseases, Metabolic
 Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Calcium Metabolism Disorders
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents