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
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Vitamin D Deficiency Secondary Hyperparathyroidism Osteomalacia | Drug: 25 OH vitamin D | Phase 4 |

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 |

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
|
- plasma vitamin D level [ Time Frame: 6 months ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
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

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
Israel | |
Endocrinology Clinic, Clalit Health Services | |
Jerusalem., Israel |
Principal Investigator: | Muriel Metzger, MD | Clalit Health Services, Jerusalem, Israel | |
Principal Investigator: | Anat Tsur, MD | Clalit Health Services, Jerusalem, Israel |
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 |