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

Not Applicable

Completed

• Conditions: Hyperbilirubinemia
• Interventions: Drug: Vitamin D3; Procedure: Phototherapy

• Registration Number: NCT07098234
• Lead Sponsor: Muhammad Aamir Latif

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.

Detailed Description

If vitamin-D has been found effective as an adjuvant to phototherapy in the treatment of exaggerated physiological hyperbilirubinemia, it may help to reduce the serum bilirubin level rapidly. It may also reduce the complications by shortening the duration of phototherapy to offer better patient compliance and better patient outcomes.

Study Timeline

• Study Start: 2022-07-01
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Study First Submitted: 2025-07-25
• Study First Submitted QC: 2025-07-25
• Status Verified: 2025-08
• Study First Posted: 2025-08-01
• Last Update Submitted: 2025-08-04
• Last Update Posted: 2025-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin D3 group	Vitamin D3	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.
Phototherapy group	Phototherapy	Neonates received only phototherapy for 72 hours.
Vitamin D3 group	Phototherapy	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.

Primary Outcome Measures

Name	Time	Method
Bilirubin reduction comparison	72 hours	Net reductions in bilirubin levels in two groups after 72 hours were compared.

Trial Locations

Locations (1)

Mayo Hospital; 🇵🇰 Lahore, Punjab, Pakistan