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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2022-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Hyperbilirubinemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vitamin D3 group

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.

Group Type EXPERIMENTAL

Vitamin D3

Intervention Type 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

Intervention Type PROCEDURE

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

Phototherapy group

Neonates received only phototherapy for 72 hours.

Group Type EXPERIMENTAL

Phototherapy

Intervention Type PROCEDURE

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

Interventions

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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 until the serum bilirubin level was out of phototherapy range or a maximum of 72 hours as an adjuvant therapy to phototherapy.

Intervention Type DRUG

Phototherapy

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

3 Days

Maximum Eligible Age

8 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No