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

Primary Purpose

Osteopenia of Prematurity

Status

Completed

Phase

Phase 2

Locations

Egypt

Study Type

Interventional

Intervention

Low Dose Vitamin D

High Dose Vitamin D

About this trial

This is an interventional prevention trial for Osteopenia of Prematurity

Eligibility Criteria

1 Day - 2 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

200 IU/d vitamin D

1600 IU/d vitamin D

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

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

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.

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.

Bone fracture

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

Intracortical resorption

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

Losing the sharp bone border (fraying)

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

Cupping of metaphyseal edge of bone

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

Widening of the distal end of the metaphysis of bone

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04768439

First Posted

February 21, 2021

Last Updated

September 11, 2021

Sponsor

Alexandria University

1. Study Identification

Unique Protocol Identification Number

NCT04768439

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Completed

Study Start Date

August 10, 2020 (Actual)

Primary Completion Date

April 20, 2021 (Actual)

Study Completion Date

April 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteopenia of Prematurity

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

200 IU/d vitamin D

Arm Type

Experimental

Arm Description

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

Arm Title

1600 IU/d vitamin D

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Low Dose Vitamin D

Other Intervention Name(s)

1,25-Dihydroxycholecalciferol

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

High Dose Vitamin D

Other Intervention Name(s)

1,25-Dihydroxycholecalciferol

Intervention Description

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

Primary Outcome Measure Information:

Title

Calcium level and activity

Description

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

Title

Phosphorus level and activity

Description

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

Title

Alkaline phosphatase level and activity

Description

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

Title

25-Hydroxy Vitamin D

Description

Time Frame

six weeks

Title

Bone fracture

Description

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

Time Frame

six weeks

Title

Intracortical resorption

Description

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

Time Frame

six weeks

Title

Losing the sharp bone border (fraying)

Description

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

Time Frame

six weeks

Title

Cupping of metaphyseal edge of bone

Description

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

Time Frame

six weeks

Title

Widening of the distal end of the metaphysis of bone

Description

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

Time Frame

six weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Day

Maximum Age & Unit of Time

2 Months

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marwa M Farrag, PhD

Organizational Affiliation

Faculty of Medicine, Alexandria University, Egypt

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Alexandria

ZIP/Postal Code

21131

Country

Egypt

12. IPD Sharing Statement

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

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