A clinical trial to study the effects of two different dosages of Vitamin D in preterm neonates

Randomised Control Trial of efficacy and outcome of Vitamin D supplementation in preterm neonates

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/08/027251

Enrollment

190

Registered

2020-08-19

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

None listed

Interventions

Intervention1: Vitamin D: 200 IU once daily per oral for 4 weeks Control Intervention1: None: Neonate will not receive additional 200 units Vitamin D

Eligibility

Inclusion criteria

Inclusion criteria: All preterm infants (28-34 weeks) born at or brought to NICU, KMC Manipal within 24 hours of life.

Exclusion criteria

Exclusion criteria: - Unable to tolerate 120 ml/kg enteral feeds by Day 14 of life - Requiring surgical intervention - Necrotizing enterocolitis - Discharged against medical advice - Expired

Design outcomes

Primary

Measure	Time frame
200 IU of supplementation to the current regimen of preterm feeding is necessary and sufficient to decrease morbidity in terms of decreasing the need for invasive/ non-invasive ventilation, the rate of culture proven or clinically suspected sepsis, and the duration and intensity of hyperbilirubinemia to clinically significant levels.Timepoint: 28 days	—

Secondary

Measure	Time frame
Vit D supplementation aids in maintaining calcium homeostasisTimepoint: 28 days	—

Countries

India

Contacts

Public ContactVinith C

Kasturba Medical College

leslielewis1@gmail.com9449208476

Outcome results