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OpenTrials
Completed

NCT Number: NCT06650293

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.

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Key information

Age range

3 day–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Lahore, Pakistan

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Vitamin D

Drug

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

Primary outcomes

  1. Total Serum bilirubin levels

    Time frame: 5 days

    Total Serum bilirubin levels evaluated

Sponsors and collaborators

Lead sponsor

Muhammad Aamir Latif

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Oct 21, 2024
Registry last updated
Oct 21, 2024

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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