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Vitamin D Status in Males in Jerusalem Area and Its Correlation to Parathyroid Hormone (PTH) Level and Bone Mineral Density
This study has been completed.
Sponsor:
Clalit Health Services
Information provided by (Responsible Party):
Metzger Muriel, Clalit Health Services
ClinicalTrials.gov Identifier:
NCT01025128
First received: December 1, 2009
Last updated: July 18, 2014
Last verified: July 2014
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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 Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Screening |
Resource links provided by NLM:
Further study details as provided by Metzger Muriel, Clalit Health Services:
Primary Outcome Measures:
- plasma vitamin D level [ Time Frame: 6 months ]
Secondary Outcome Measures:
- bone mineral density before vitamin D supplementation [ Time Frame: 8 months ]
- plasma PTH level [ Time Frame: 6 months ]
- bone mineral density after vitamin D supplementation in vitamin D deficient subjects [ Time Frame: 13 months ]
| Enrollment: | 210 |
| Study Start Date: | January 2010 |
| Study Completion Date: | July 2014 |
| Primary Completion Date: | July 2014 (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 (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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01025128
Please refer to this study by its ClinicalTrials.gov identifier: 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
| Responsible Party: | Metzger Muriel, MD, Clalit Health Services |
| ClinicalTrials.gov Identifier: | NCT01025128 History of Changes |
| Other Study ID Numbers: |
K129/09 |
| Study First Received: | December 1, 2009 |
| Last Updated: | July 18, 2014 |
Additional relevant MeSH terms:
|
Hyperparathyroidism Vitamin D Deficiency Hyperparathyroidism, Secondary Osteomalacia Parathyroid Diseases Endocrine System Diseases Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Rickets Bone Diseases, Metabolic |
Bone Diseases Musculoskeletal Diseases Calcium Metabolism Disorders Metabolic Diseases Vitamins Vitamin D Ergocalciferols Micronutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents |
ClinicalTrials.gov processed this record on June 23, 2017