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A study to evaluate the effect of Calcium on the duration of blue light therapy required for the treatment of babies with jaundice

Evaluation of efficacy of Oral Calcium Phosphate as an adjunct to standard of care regular phototherapy in cases of neonatal jaundice: A hospital based double blind randomized control trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/03/041203
Enrollment
80
Registered
2022-03-21
Start date
Unknown
Completion date
Unknown
Last updated
2022-04-04

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

Conditions

Health Condition 1: P599- Neonatal jaundice, unspecified

Interventions

Intervention1: Oral calcium Phosphate along with standard of care phototherapy: Weight appropriate dose of drop Calcium Phosphate (@75-80mg/kg/day) prepared from pulverized tablet Ostocalcium plus in

Sponsors

Dr Arnab Ghorui
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All newborns of either sex with neonatal jaundice requiring phototherapy as per AAP(American Academic of Pediatrics)/NICE(National Institute for Health & Care Excellence) guidelines

Exclusion criteria

Exclusion criteria: 1.Newborns kept on nil per mouth due to any cause. 2.Newborns with conjugated hyperbilirubinemia. (Direct bilirubin >2mg/dl or direct bilirubin is >20% of total serum bilirubin). 3.Newborns with renal anomalies on antenatal ultrasound. 4.Newborn at any point of time requiring calcium supplements or therapy for any medical indication.

Design outcomes

Primary

MeasureTime frame
To compare the rate of fall of total serum bilirubin in both the groups. Timepoint: Starting point- TSB at the beginning of phototherapy Thereafter, TSB every 6th hourly End point-When TSB comes 2md/dl below the phototherapy cut off for that hours of life

Secondary

MeasureTime frame
Incidence of rebound hyperbilirubinemia in proportion/percentageTimepoint: 6 hours after stoppage of phototherapy;Rate of fall of bilirubin in mg/dl/hour.Timepoint: Total serum bilirubin 6 hours after starting of phototherapy, then 12th hourly till total serum bilirubin comes 2mg/dl below the phototherapy cutoff for that hours of life

Countries

India

Contacts

Public ContactDr Arnab Ghorui

All India Institute of Medical Sciences, Patna

cmkumar@aiimspatna.org9810730206

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 5, 2026