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NCT Number: NCT07098234

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

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.

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Key information

Conditions

Hyperbilirubinemia Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

3 day–8 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Hospital

Lahore, Punjab Province, 54000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Phototherapy

Procedure

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

Primary outcomes

  1. Bilirubin reduction comparison

    Time frame: 72 hours

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

Sponsors and collaborators

Lead sponsor

Muhammad Aamir Latif

Other

Registry information

Official study title

Determination of the Effect of Vitamin-D as an Adjuvant to Phototherapy in Reduction of Indirect Serum Bilirubin Among Neonates With Exaggerated Physiological Hyperbilirubinemia.

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 1, 2025
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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