NCT04768439

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2020

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 10, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 24, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2021

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

September 14, 2021

Status Verified

September 1, 2021

Enrollment Period

8 months

First QC Date

February 21, 2021

Last Update Submit

September 11, 2021

Conditions

Osteopenia of Prematurity

Outcome Measures

Primary Outcomes (9)

  • 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

  • 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

  • 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

  • 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

  • Bone fracture

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

    six weeks

  • Intracortical resorption

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

    six weeks

  • Losing the sharp bone border (fraying)

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

    six weeks

  • Cupping of metaphyseal edge of bone

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

    six weeks

  • Widening of the distal end of the metaphysis of bone

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

    six weeks

Study Arms (2)

200 IU/d vitamin D

EXPERIMENTAL

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

Drug: Low Dose Vitamin D

1600 IU/d vitamin D

EXPERIMENTAL

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

Drug: High Dose Vitamin D

Interventions

Low Dose Vitamin DDRUG

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

Also known as: 1,25-Dihydroxycholecalciferol
200 IU/d vitamin D
High Dose Vitamin DDRUG

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

Also known as: 1,25-Dihydroxycholecalciferol
1600 IU/d vitamin D

Eligibility Criteria

Age1 Day - 2 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Newborns with gestational age of ≤ 32 weeks and birth weight ≤ 1500 g.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Alexandria, 21131, Egypt

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic

Interventions

Vitamin DCalcitriol

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsDihydroxycholecalciferolsHydroxycholecalciferolsCholecalciferolCholestenesCholestanesSterolsMembrane LipidsLipids

Study Officials

  • Marwa M Farrag, PhD

    Faculty of Medicine, Alexandria University, Egypt

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer in Pediatrics, Faculty of Medicine

Study Record Dates

First Submitted

February 21, 2021

First Posted

February 24, 2021

Study Start

August 10, 2020

Primary Completion

April 20, 2021

Study Completion

April 30, 2021

Last Updated

September 14, 2021

Record last verified: 2021-09

Locations

EG(1)