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

NCT ID: NCT04768439

Last Updated: 2021-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-10

Study Completion Date

2021-04-30

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).

Conditions

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Osteopenia of Prematurity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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200 IU/d vitamin D

Patients will receive low-dose vitamin D (200 IU/d)

Group Type EXPERIMENTAL

Low Dose Vitamin D

Intervention Type DRUG

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

1600 IU/d vitamin D

Patients will receive high-dose vitamin D (1600 IU/d)

Group Type EXPERIMENTAL

High Dose Vitamin D

Intervention Type DRUG

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

Interventions

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Low Dose Vitamin D

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

Intervention Type DRUG

High Dose Vitamin D

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

Intervention Type DRUG

Other Intervention Names

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1,25-Dihydroxycholecalciferol 1,25-Dihydroxycholecalciferol

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
Minimum Eligible Age

1 Day

Maximum Eligible Age

2 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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Marwa Mohamed Farag

Lecturer in Pediatrics, Faculty of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marwa M Farrag, PhD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, Alexandria University, Egypt

Locations

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

Alexandria, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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00007555-00015712

Identifier Type: -

Identifier Source: org_study_id

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