Effect of Vitamin D Supplementation as Adjuvant Therapy in Neonatal Jaundice in Combination With Phototherapy

Neonatal jaundice frequently occur during initial week of life. Neonatal jaundice is one of the leading causes of hospital admission and readmission. Some studies have suggested that the healthy newborns with hyperbilirubinemia outside the physiological range have notably reduced serum vitamin D levels. This deficiency is inversely associated with neonatal hyperbilirubinemia, suggesting that low vitamin D levels could be a potential risk factor for jaundice among neonates.

Study Overview

• Status: Completed
• Conditions: Neonatal Jaundice
• Intervention / Treatment: Drug: Vitamin D

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Lahore, Pakistan
    • Pediatric Medicine Department University of Child Health Sciences, Children's Hospital Lahore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Both genders
• Admitted between 3-28 days of age.
• Indirect hyperbilirubinemia with TSB levels between 14-20 mg/dL
• Born via either cesarean or vaginal delivery
• Birth weight greater than 2500 grams

Exclusion Criteria:

• Prior phototherapy treatment
• Preterm birth (gestational age below 37 weeks).
• SpO2 < 95% at the time of admission
• Severe respiratory distress or failure
• Neonatal sepsis
• Congenital anomalies
• Parents/guardians unwilling to let their neonates be part of this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group-A; Neonates receive phototherapy plus vitamin D	Drug: Vitamin D; Vitamin D supplementation as vitamin D, 2 drops i.e., 800 IU daily for 5 days.
No Intervention: Group-B; Neonates will receive only phototherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Serum bilirubin levels	Total Serum bilirubin levels evaluated	5 days

Collaborators and Investigators

• Sponsor: Muhammad Aamir Latif
• Investigators: Principal Investigator: Zeeshan Afzal, FCPS, Pediatric Medicine Department University of Child Health Sciences, Children's Hospital Lahore; Study Director: Wajiha Rizwan, FCPS, Pediatric Medicine Department University of Child Health Sciences, Children's Hospital Lahore

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2022
• Primary Completion (Actual): November 9, 2022
• Study Completion (Actual): November 10, 2022

Study Registration Dates

• First Submitted: October 18, 2024
• First Submitted That Met QC Criteria: October 18, 2024
• First Posted (Actual): October 21, 2024

Study Record Updates

• Last Update Posted (Actual): October 21, 2024
• Last Update Submitted That Met QC Criteria: October 18, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infant, Newborn, Diseases; Skin Manifestations; Hyperbilirubinemia; Hyperbilirubinemia, Neonatal; Jaundice; Jaundice, Neonatal; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: UCHSL-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No