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

Osteopenia of Prematurity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04768439
• Other study ID #: 00007555-00015712
• Status: Completed
• Phase: Phase 2
• Start date: August 10, 2020
• Est. completion date: April 30, 2021

Study information

• Verified date: September 2021
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 30, 2021
• Est. primary completion date: April 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Months

Eligibility

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

Related Conditions & MeSH terms

• Bone Diseases, Metabolic
• Osteopenia of Prematurity
• Premature Birth

Intervention

Drug:
• Low Dose Vitamin D
Patients will receive a 200 IU/d vitamin D since they tolerate full enteral nutrition.
• High Dose Vitamin D
Patients will receive 1600 IU/d vitamin D since they tolerate full enteral nutrition.

Locations

Country	Name	City	State
Egypt	Neonatal Intensive Care Unit (NICU) of Alexandria University Maternity Hospital.	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Bone fracture	This will be evaluated using an x-ray of left wrist	six weeks
Primary	Intracortical resorption	This will be evaluated using an x-ray of left wrist	six weeks
Primary	Losing the sharp bone border (fraying)	This will be evaluated using an x-ray of left wrist	six weeks
Primary	Cupping of metaphyseal edge of bone	This will be evaluated using an x-ray of left wrist	six weeks
Primary	Widening of the distal end of the metaphysis of bone	This will be evaluated using an x-ray of left wrist	six weeks