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

NCT06650293 | Completed

• 1 other identifier: UCHSL-1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neonatal Jaundice

Outcome Measures

Primary Outcomes (1)

• Total Serum bilirubin levels

  Total Serum bilirubin levels evaluated

  5 days

Study Arms (2)

Group-A

EXPERIMENTAL

Neonates receive phototherapy plus vitamin D

Drug: Vitamin D

Group-B

NO INTERVENTION

Neonates will receive only phototherapy

Interventions

Vitamin D DRUG

Vitamin D supplementation as vitamin D, 2 drops i.e., 800 IU daily for 5 days.

Group-A

Eligibility Criteria

• Age: 3 Days - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Muhammad Aamir Latif: lead

Study Sites (1)

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

Lahore, Pakistan

Location

MeSH Terms

Conditions

Jaundice, Neonatal

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Hyperbilirubinemia, Neonatal; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Zeeshan Afzal, FCPS

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

  PRINCIPAL INVESTIGATOR

• Wajiha Rizwan, FCPS

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Consultant

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: October 18, 2024
• First Posted: October 21, 2024
• Study Start: May 10, 2022
• Primary Completion: November 9, 2022
• Study Completion: November 10, 2022
• Last Updated: October 21, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)