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

Muhammad Aamir Latif

Status: Completed

Conditions: Hyperbilirubinemia

Treatments: Drug: Vitamin D3; Procedure: Phototherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07098234

Dr-Hafsah-LHR

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 3 to 8 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Vitamin D3 group

Experimental group

Description:

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.

Treatment:

Procedure: Phototherapy

Drug: Vitamin D3

Phototherapy group

Experimental group

Description:

Neonates received only phototherapy for 72 hours.

Treatment:

Procedure: Phototherapy