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In this study the effects of low and high doses of prophylactic vitamin D on biochemical and radiological manifestations of osetopenia of prematurity will be tested.
The study will be conducted on (80) preterm infants that fulfill the eligibility criteria and delivered at Alexandria University Maternity Hospital (AUMH).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 200 IU/d vitamin D | Experimental | Patients will receive low-dose vitamin D (200 IU/d) |
|
| 1600 IU/d vitamin D | Experimental | Patients will receive high-dose vitamin D (1600 IU/d) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Dose Vitamin D | Drug | Patients will receive a 200 IU/d vitamin D since they tolerate full enteral nutrition. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Calcium level and activity | Serum calcium level will be measured and analyzed using Advia 1800 chemistry system (Simens Germany). Normal level: 8.5 to 10.5 mg/dl | six weeks |
| Phosphorus level and activity | Serum phosphorus level will be measured and analyzed using Advia 1800 chemistry system (Simens Germany). Normal level: 3.4 to 4.5 mg/dl | six weeks |
| Alkaline phosphatase level and activity | Serum alkaline phosphate level will be measured and analyzed using Advia 1800 chemistry system (Simens Germany). Normal level: 50-100 U/L. | six weeks |
| 25-Hydroxy Vitamin D | Serum 25-Hydroxy Vitamin D level will be measured and analyzed using Electrochemilumiescence binding assay on cobas e immunoassay analyzer. The reference range of the total 25(OH)D level is 25-80 ng/mL. | six weeks |
| Bone fracture | This will be evaluated using an x-ray of left wrist | six weeks |
| Intracortical resorption | This will be evaluated using an x-ray of left wrist | six weeks |
| Losing the sharp bone border (fraying) | This will be evaluated using an x-ray of left wrist | six weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marwa M Farrag, PhD | Faculty of Medicine, Alexandria University, Egypt | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neonatal Intensive Care Unit (NICU) of Alexandria University Maternity Hospital. | Alexandria | 21131 | Egypt |
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| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| D002117 | Calcitriol |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| High Dose Vitamin D | Drug | Patients will receive 1600 IU/d vitamin D since they tolerate full enteral nutrition. |
|
|
| Cupping of metaphyseal edge of bone |
This will be evaluated using an x-ray of left wrist |
| six weeks |
| Widening of the distal end of the metaphysis of bone | This will be evaluated using an x-ray of left wrist | six weeks |
| D004100 |
| Dihydroxycholecalciferols |
| D006887 | Hydroxycholecalciferols |
| D002762 | Cholecalciferol |
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013261 | Sterols |
| D008563 | Membrane Lipids |
| D008055 | Lipids |