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

Determination of the Effect of Vitamin-D as an Adjuvant to Phototherapy in Reduction of Indirect Serum Bilirubin Among Neonates With Exaggerated Physiological Hyperbilirubinemia.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07098234
Enrollment
90
Registered
2025-08-01
Start date
2022-07-01
Completion date
2022-12-31
Last updated
2025-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperbilirubinemia

Brief summary

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.

Detailed 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.

Interventions

DRUGVitamin 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.

PROCEDUREPhototherapy

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

Sponsors

Muhammad Aamir Latif
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
3 Days to 8 Days
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Bilirubin reduction comparison72 hoursNet reductions in bilirubin levels in two groups after 72 hours were compared.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026