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

Phase 2

Completed

• Conditions: Osteopenia of Prematurity
• Interventions: Drug: Low Dose Vitamin D; Drug: High Dose Vitamin D

• Registration Number: NCT04768439
• Lead Sponsor: Alexandria University

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).

Study Timeline

• Study Start: 2020-08-10
• Study First Submitted: 2021-02-21
• Study First Submitted QC: 2021-02-21
• Study First Posted: 2021-02-24
• Primary Completion: 2021-04-20
• Study Completion: 2021-04-30
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-11
• Last Update Posted: 2021-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
200 IU/d vitamin D	Low Dose Vitamin D	Patients will receive low-dose vitamin D (200 IU/d)
1600 IU/d vitamin D	High Dose Vitamin D	Patients will receive high-dose vitamin D (1600 IU/d)

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Neonatal Intensive Care Unit (NICU) of Alexandria University Maternity Hospital.; 🇪🇬 Alexandria, Egypt