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IRCT20260627069958N1 IRCT 2026-07-09 Shahid Beheshti University of Medical Sciences Effect of Oral Zinc Supplementation on Serum Bilirubin Reduction in Neonates with Jaundice Effect of Oral Zinc Supplementation on Serum Bilirubin Reduction in Hospitalized Neonates with Jaundice in Mofid and Mahdieh Hospitals: A Randomized Double-Blind Clinical Trial 2026-07-23 anticipated 100 Complete https://irct.ir/trial/91220 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: To ensure balanced group sizes throughout the enrollment process, block randomization with a fixed block size of four will be used. Neonates will be randomized in blocks of four. Randomization will be stratified by sex and baseline total serum bilirubin level (<18 mg/dL and ≥18 mg/dL) to ensure a balanced distribution of the initial severity of hyperbilirubinemia between the intervention and control groups. The random allocation sequence will be generated by an independent individual who is not involved in the study using Random Allocation Software. Allocation assignments will be placed in sequentially numbered, opaque, sealed envelopes to ensure allocation concealment. Upon enrollment of each eligible neonate, the next envelope in the predetermined sequence will be opened, and only the designated pharmacist responsible for preparing the study intervention will be informed of the treatment assignment. The individual responsible for generating the randomization sequence and maintaining the allocation envelopes will have no involvement in participant recruitment, clinical management, outcome assessment, data collection, or statistical analysis, Blinding description: This study will be conducted as a double-blind clinical trial. The parents or legal guardians of the neonates, as well as all members of the research team, including the treating physicians, ward nurses, the researcher responsible for data collection, the outcome assessor, and the statistician, will remain blinded to group allocation throughout the study. Only the designated pharmacist responsible for preparing the study intervention will be aware of the allocation codes. The allocation codes will remain concealed until completion of the final statistical analysis, unless emergency unblinding is required due to a serious adverse event or when knowledge of the treatment assignment is deemed necessary for appropriate clinical management. 3 Neonatal jaundice. Intervention 1: Intervention group: In the intervention group, neonates will receive standard treatment plus oral zinc supplementation at a dose of 10 mg/day. Standard neonatal jaundice care will include phototherapy, adequate feeding, and routine monitoring of vital signs and clinical status. Phototherapy devices and settings will be identical in both groups according to the unit protocol. Intervention 2: Control group: In the control group, neonates will receive standard care plus a placebo identical in appearance, volume, color, and packaging. Standard neonatal jaundice management will include phototherapy, adequate feeding, and routine monitoring of vital signs and clinical assessment. Phototherapy devices and settings will be identical in both groups according to the unit protocol. Yes - There is a plan to make this available What will be shared: All data collected during the study will be de-identified and made available for data sharing. When: The de-identified study data will be available for sharing upon submission of the manuscript derived from this study to a peer-reviewed journal. To whom: Access to the de-identified study data will be available to all interested readers. Conditions: The complete de-identified dataset may be used for pooled analyses or meta-analyses upon reasonable request to the corresponding author and with the necessary approval. Where to obtain: Vahide Zeinali, email: v.zeinali4183@sbmu.ac.ir How to obtain: Upon publication of the study, a public electronic link to the de-identified dataset will be provided. During the publication process (before online publication), researchers may request access to the data by contacting the corresponding author via email and providing the purpose and details of their request. Subject to approval by the research team, the requested data will be shared within 24 hours. Comments:
public Minou Fallahi
Dr. Shariati Ave, Mofid Children's Hospital, Tehran, Iran.
Tehran Iran (Islamic Republic of) 1546815514 +98 21 2222 7033 minou_fallahi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Minou Fallahi
Dr. Shariati Ave, Mofid Children's Hospital, Tehran, Iran.
Tehran Iran (Islamic Republic of) 1546815514 +98 21 2222 3370 minou_fallahi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Neonates diagnosed with indirect neonatal hyperbilirubinemia requiring phototherapy, as determined by the treating physician according to established institutional guidelines. Neonates with a gestational age of 35–42 weeks. Initiation of enteral feeding with adequate tolerance of oral feeding. Written informed consent from the parents or legal guardian before enrollment. no limit no limit Both Jaundice presentation within the first 24 hours of life. Development of sepsis, severe systemic illness, or hemodynamic instability. Requirement for mechanical ventilation. Presence of major congenital anomalies or known genetic syndromes. Concomitant administration of any medication or dietary supplement with a potential bilirubin-lowering effect. Feeding intolerance, recurrent vomiting, or gastrointestinal disorders that could interfere with supplement administration. Requirement for exchange transfusion at enrollment or during the initial hours of hospitalization before completion of the study protocol. Evidence of hemolysis. Withdrawal of parental or legal guardian consent at any stage of the study. P59.3 Neonatal jaundice from breast milk inhibitor Treatment - Drugs Placebo Intervention group: In the intervention group, neonates will receive standard treatment plus oral zinc supplementation at a dose of 10 mg/day. Standard neonatal jaundice care will include phototherapy, adequate feeding, and routine monitoring of vital signs and clinical status. Phototherapy devices and settings will be identical in both groups according to the unit protocol. Control group: In the control group, neonates will receive standard care plus a placebo identical in appearance, volume, color, and packaging. Standard neonatal jaundice management will include phototherapy, adequate feeding, and routine monitoring of vital signs and clinical assessment. Phototherapy devices and settings will be identical in both groups according to the unit protocol. The primary outcome will be total serum bilirubin (TSB) level at 48 hours after initiation of the intervention. Timepoint: 48 hours after initiation of the intervention. Method of measurement: Neonatal bilirubin level in this study will be measured as total serum bilirubin using a venous blood sample and standard laboratory biochemical analysis (photometric bilirubinometry) performed in the hospital laboratory. Total serum bilirubin (TSB) level at 12 hours after initiation of the intervention. Timepoint: 12 hours after initiation of the intervention. Method of measurement: Neonatal bilirubin level in this study will be measured as total serum bilirubin using a venous blood sample and standard laboratory biochemical analysis (photometric bilirubinometry) performed in the hospital laboratory. Total serum bilirubin (TSB) level at 24 hours after initiation of the intervention. Timepoint: 24 hours after initiation of the intervention. Method of measurement: Neonatal bilirubin level in this study will be measured as total serum bilirubin using a venous blood sample and standard laboratory biochemical analysis (photometric bilirubinometry) performed in the hospital laboratory. Mean duration of phototherapy (hours). Timepoint: Measurement of time in hours from the actual initiation of the device to its complete discontinuation. Method of measurement: Measurement of time in hours from the actual initiation of the device to its complete discontinuation. Mean length of hospital stay (days). Timepoint: Measurement of hospital stay duration from admission to discharge. Method of measurement: Measurement of hospital stay duration from admission to discharge. Shahid Beheshti University of Medical Sciences Approved 2026-06-16 Ethics committee of Shahid Beheshti University of Medical Sciences Sixth Floor, Building No. 2, Shahid Beheshti University of Medical Sciences, Tehran, Yemen Street, Arabi Street, Shahid Chamran Highway, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)