Osteopenia of Prematurity
Conditions
Brief summary
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
The study will be conducted on (80) preterm infants that fulfill the eligibility criteria and delivered at Alexandria University Maternity Hospital (AUMH).
Interventions
DRUGLow Dose Vitamin D
Patients will receive a 200 IU/d vitamin D since they tolerate full enteral nutrition.
Patients will receive 1600 IU/d vitamin D since they tolerate full enteral nutrition.
Sponsors
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Days to 2 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Calcium level and activity | six weeks | Serum calcium level will be measured and analyzed using Advia 1800 chemistry system (Simens Germany). Normal level: 8.5 to 10.5 mg/dl |
| Phosphorus level and activity | six weeks | Serum phosphorus level will be measured and analyzed using Advia 1800 chemistry system (Simens Germany). Normal level: 3.4 to 4.5 mg/dl |
| Alkaline phosphatase level and activity | six weeks | Serum alkaline phosphate level will be measured and analyzed using Advia 1800 chemistry system (Simens Germany). Normal level: 50-100 U/L. |
| 25-Hydroxy Vitamin D | six weeks | 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. |
| Bone fracture | six weeks | This will be evaluated using an x-ray of left wrist |
| Intracortical resorption | six weeks | This will be evaluated using an x-ray of left wrist |
| Losing the sharp bone border (fraying) | six weeks | This will be evaluated using an x-ray of left wrist |
| Cupping of metaphyseal edge of bone | six weeks | This will be evaluated using an x-ray of left wrist |
| Widening of the distal end of the metaphysis of bone | six weeks | This will be evaluated using an x-ray of left wrist |
Countries
Egypt
Outcome results
None listed