Low and High Doses of Prophylactic Vitamin D in Prevention of Osteopenia of Prematurity

Study Overview
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Brief Summary
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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.

Detailed Description
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The study will be conducted on (80) preterm infants that fulfill the eligibility criteria and delivered at Alexandria University Maternity Hospital (AUMH).

Official Title
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Comparison Between Low and High Doses of Prophylactic Vitamin D in Prevention of Osteopenia of Prematurity

Conditions
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Osteopenia of Prematurity

Intervention / Treatment
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* Drug: Low Dose Vitamin D
* Drug: High Dose Vitamin D


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Newborns with gestational age of ≤ 32 weeks and birth weight ≤ 1500 g. Exclusion Criteria: Newborns whose mothers were taking specific medications interacting with vitamin D metabolism (e.g., anticonvulsants, diuretics) Being NPO (nothing per oral) for more than 2 wks Gestational age more than 32 weeks Birth weight more than 1500 grams

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 2 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 200 IU/d vitamin D<br>Patients will receive low-dose vitamin D (200 IU/d) | Drug: Low Dose Vitamin D<br>* Patients will receive a 200 IU/d vitamin D since they tolerate full enteral nutrition.<br>* Other names: 1,25-Dihydroxycholecalciferol;|
| Experimental: 1600 IU/d vitamin D<br>Patients will receive high-dose vitamin D (1600 IU/d) | Drug: High Dose Vitamin D<br>* Patients will receive 1600 IU/d vitamin D since they tolerate full enteral nutrition.<br>* Other names: 1,25-Dihydroxycholecalciferol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 
| 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 |