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

Muhammad Aamir Latif

Status: Completed

Conditions: Neonatal Jaundice

Treatments: Drug: Vitamin D

Study type: Interventional

Funder types: Other

Identifiers

NCT06650293

UCHSL-1

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 3 to 28 days old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

Group-A

Experimental group

Description:

Neonates receive phototherapy plus vitamin D

Treatment:

Drug: Vitamin D

Group-B

No Intervention group

Description:

Neonates will receive only phototherapy