Effect of Vitamin-D as an Adjuvant to Phototherapy in Reduction of Indirect Serum Bilirubin

NCT07098234 | Completed

• 1 other identifier: Dr-Hafsah-LHR
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The study aimed at filling the gaps by evaluating the effectiveness of vitamin-D as an adjuvant to phototherapy in reduction of indirect serum bilirubin among neonates with exaggerated physiological hyperbilirubinemia.

Conditions

Hyperbilirubinemia

Outcome Measures

Primary Outcomes (1)

• Bilirubin reduction comparison

  Net reductions in bilirubin levels in two groups after 72 hours were compared.

  72 hours

Study Arms (2)

Vitamin D3 group

EXPERIMENTAL

Neonates were given vitamin D3 (cholecalciferol) in an oral drops formulation (400 IU/drop), at a dose of 400 IU once a day for 72 hours as an adjuvant therapy to phototherapy.

Drug: Vitamin D3; Procedure: Phototherapy

Phototherapy group

EXPERIMENTAL

Neonates received only phototherapy for 72 hours.

Procedure: Phototherapy

Interventions

Vitamin D3 DRUG

Neonates were given vitamin D3 (cholecalciferol) in an oral drops formulation (400 IU/drop), at a dose of 400 IU once a day until the serum bilirubin level was out of phototherapy range or a maximum of 72 hours as an adjuvant therapy to phototherapy.

Vitamin D3 group

Phototherapy PROCEDURE

Neonates received only phototherapy until the serum bilirubin level was out of phototherapy range or a maximum of 72 hours.

Phototherapy group; Vitamin D3 group

Eligibility Criteria

• Age: 3 Days - 8 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Newborns of any gender
• Age of 3rd day of life to 8th day of life
• Gestation age ≥37 to ≤42 weeks
• Total serum bilirubin level more than 12.9 mg/dL
• Weight \> 2.5 kg

You may not qualify if:

• Congenital defects (on physical examination)
• Large for gestational age infant
• Rh Incompatibility (were excluded on basis of blood grouping of mother and baby)
• ABO Incompatibility (were excluded on basis of blood grouping of mother and baby)
• Neonatal sepsis

Sponsors & Collaborators

• Muhammad Aamir Latif: lead

Study Sites (1)

Mayo Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Hyperbilirubinemia

Interventions

Cholecalciferol; Phototherapy

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Therapeutics

Study Officials

• Hafsah Naz

  Mayo Hospital, Lahore, Pakistan

  PRINCIPAL INVESTIGATOR

• Muhammad Ashfaq

  Mayo Hospital, Lahore, Pakistan

  PRINCIPAL INVESTIGATOR

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

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: August 1, 2025
• Study Start: July 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)