Comparison of higher dosage with the lower standard dosage of phosphate supplementation in preterm neonates and assessment of improvement in bone health .

Comparison of two doses of phosphate supplementation and its effect on bone mineralization in preterm neonates of less than or equal to 32 weeks gestational age. An open-label, parallel-group, superiority randomized controlled trial

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/01/102520

Enrollment

Registered

2026-01-30

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-02

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

Conditions

Health Condition 1: P073- Preterm [premature] newborn [other]

Interventions

Intervention1: Phosphate dose of 110 to 130 mg/kg/day: Neonates less than equal to 32 weeks Control Intervention1: Phosphate dose of 60 to 80 mg/kg/day: Neonates less than or equal to 32 weeks

Eligibility

Inclusion criteria

Inclusion criteria: Preterm neonates born less than or equal to 32 weeks on full enteral nutrition of 150 mg/kg/day.

Exclusion criteria

Exclusion criteria: 1. Major congenital anomalies involving gastro-enteral tract or skeletal dysplasia. 2. Not stable to be started on enteral nutrition or shifted for DXA by day 14. 3. Severe renal impairment (oliguria/anuria/creatinine above local cutoff)/ PDA/congenital heart disease requiring volume restriction beyond 120ml/kg/day of fluid. 4. Inborn errors of metabolism affecting feeding and mineral handling. 5. Parents not consented to participate.

Design outcomes

Primary

Measure	Time frame
To compare the mean difference in whole-body bone mineral density (BMD, in grams/cm )Timepoint: When a preterm infant reaches 37 to 40 weeks postmenstrual age.	—

Secondary

Measure	Time frame
To compare the mean difference in whole-body bone mineral content (BMC, in grams)Timepoint: When a preterm infant reaches 37 to 40 weeks postmenstrual age.;Serum calcium levels as part of MBDP evaluation and management.Timepoint: The first time at 3 to 4 weeks postnatal age and followed up every 2 weeks till postmenstrual age of 36 to 40 weeks;Serum phosphorus levels as part of MBDP evaluation and management.Timepoint: The first time at 3 to 4 weeks postnatal age and followed up every 2 weeks till postmenstrual age of 36 to 40 weeks;Alkaline phosphatase levels as part of MBDP evaluation and management.Timepoint: The first time at 3 to 4 weeks postnatal age and followed up every 2 weeks till postmenstrual age of 36 to 40 weeks;iPTH levels as part of MBDP evaluation and management. Timepoint: The first time at 3 to 4 weeks postnatal age and followed up every 2 weeks till postmenstrual age of 36 to 40 weeks;To compare the incidence of Metabolic bone disease of prematurity (MBDP).Timepoint: When a preterm infant reaches 3 to 4 weeks postmenstrual age.;To compare the mean weight gain, length gain and head circumference gainTimepoint: The measurements will be done weekly until hospital discharge and each OPD visit thereafter.	—

Measure

Time frame

To compare the mean difference in whole-body bone mineral content (BMC, in grams)Timepoint: When a preterm infant reaches 37 to 40 weeks postmenstrual age.;Serum calcium levels as part of MBDP evaluation and management.Timepoint: The first time at 3 to 4 weeks postnatal age and followed up every 2 weeks till postmenstrual age of 36 to 40 weeks;Serum phosphorus levels as part of MBDP evaluation and management.Timepoint: The first time at 3 to 4 weeks postnatal age and followed up every 2 weeks till postmenstrual age of 36 to 40 weeks;Alkaline phosphatase levels as part of MBDP evaluation and management.Timepoint: The first time at 3 to 4 weeks postnatal age and followed up every 2 weeks till postmenstrual age of 36 to 40 weeks;iPTH levels as part of MBDP evaluation and management. Timepoint: The first time at 3 to 4 weeks postnatal age and followed up every 2 weeks till postmenstrual age of 36 to 40 weeks;To compare the incidence of Metabolic bone disease of prematurity (MBDP).Timepoint: When a preterm infant reaches 3 to 4 weeks postmenstrual age.;To compare the mean weight gain, length gain and head circumference gainTimepoint: The measurements will be done weekly until hospital discharge and each OPD visit thereafter.

—

Countries

India

Contacts

Public ContactTanushree Sahoo

All India Institute of Medical Sciences, Bhubaneswar

neonat_tanushree@aiimsbhubaneswar.edu.in9646832949

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026