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

Alexandria University80 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Osteopenia of Prematurity

Interventions

Low Dose Vitamin DDRUG

Patients will receive a 200 IU/d vitamin D since they tolerate full enteral nutrition.

High Dose Vitamin DDRUG

Patients will receive 1600 IU/d vitamin D since they tolerate full enteral nutrition.

Eligibility

Sex: ALLMin age: 1 DayMax age: 2 Months

Medical Language ↔ Plain English

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

Locations (1)

Neonatal Intensive Care Unit (NICU) of Alexandria University Maternity Hospital.

Alexandria, Egypt

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: six weeks

Bone fracture

This will be evaluated using an x-ray of left wrist

Time frame: six weeks

Intracortical resorption

This will be evaluated using an x-ray of left wrist

Time frame: six weeks

Losing the sharp bone border (fraying)

This will be evaluated using an x-ray of left wrist

Time frame: six weeks

Cupping of metaphyseal edge of bone

This will be evaluated using an x-ray of left wrist

Time frame: six weeks

Data from ClinicalTrials.gov

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