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

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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-10

Study Completion Date

2022-11-10

Brief Summary

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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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Detailed Description

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Conditions

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Neonatal Jaundice

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group-A

Neonates receive phototherapy plus vitamin D

Group Type EXPERIMENTAL

Vitamin D

Intervention Type DRUG

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

Group-B

Neonates will receive only phototherapy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Vitamin D

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

3 Days

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No