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

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

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.

Study Overview

• Status: Completed
• Conditions: Osteopenia of Prematurity
• Intervention / Treatment: Drug: Low Dose Vitamin D; Drug: High Dose Vitamin D

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 21131
    • Neonatal Intensive Care Unit (NICU) of Alexandria University Maternity Hospital.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 2 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 200 IU/d vitamin D; Patients will receive low-dose vitamin D (200 IU/d)	Drug: Low Dose Vitamin D; Patients will receive a 200 IU/d vitamin D since they tolerate full enteral nutrition.; Other Names: 1,25-Dihydroxycholecalciferol
Experimental: 1600 IU/d vitamin D; Patients will receive high-dose vitamin D (1600 IU/d)	Drug: High Dose Vitamin D; Patients will receive 1600 IU/d vitamin D since they tolerate full enteral nutrition.; Other Names: 1,25-Dihydroxycholecalciferol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Alexandria University
• Investigators: Principal Investigator: Marwa M Farrag, PhD, Faculty of Medicine, Alexandria University, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2020
• Primary Completion (Actual): April 20, 2021
• Study Completion (Actual): April 30, 2021

Study Registration Dates

• First Submitted: February 21, 2021
• First Submitted That Met QC Criteria: February 21, 2021
• First Posted (Actual): February 24, 2021

Study Record Updates

• Last Update Posted (Actual): September 14, 2021
• Last Update Submitted That Met QC Criteria: September 11, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth; Bone Diseases, Metabolic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Micronutrients; Membrane Transport Modulators; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vasoconstrictor Agents; Calcium Channel Agonists; Vitamin D; Cholecalciferol; Vitamins; Ergocalciferols; Calcitriol; Dihydroxycholecalciferols
• Other Study ID Numbers: 00007555-00015712

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No