NCT06674122

Efficacy of Higher Dose Enteral Vitamin D Supplementation in Preterm 28 - 34 Weeks of Gestational Age

The Efficacy of Enteral Vitamin D Supplementation at a Dose of 800 IU Compared to 400 IU in Preterm Infants With a Gestational Age of 28-34 Weeks Admitted to the Neonatal Care Unit

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Indonesia University · Academic / Other
• Sex: All
• Age: 28 Weeks – 34 Weeks
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to learn about the effective dosage of enteral vitamin D supplementation in preterm infants with gestational age fom 28 to 34 weeks. The main questions it aims to answer is: \- Does higher dose of enteral vitamin D supplementation (800IU/day) increase vitamin D level better than standard recommended dose (400IU/day) to achieve sufficient level of vitamin D? Participants will: * Take the enteral vitamin D supplementation every fay for 28 days * Have their blood level of vitamin D examined before and after supplementation for 28 days

Detailed description

The study conducted in 2 hospitals in Jakarta region, RSCM and RSUD Koja. Preterm with 28 to 34 weeks of gestational age and fulfill the inclusion criteria will be enrolled in the study after parents signed the informed consent. Blood sample will be collected to get the baseline of vitamin D serum. The study subject will be given enteral vitamin D supplementation for 28 days (4 weeks). The dosage of vitamin D is randomized with block randomized in sealed envelope. Subjects then will be followed up to 28 days of supplementation. After 28 days of supplementation, the subjects' blood will be collected to get the vitamin D serum level. Data taken will be analyzed using IBM Statistical Product and Service Solutions (SPSS).

Conditions

• Vitamin D Supplementation

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Enteral vitamin D supplementation of 800 IU/day	Higher dose of enteral vitamin D supplementations (800 IU/day) are given for 28 days, and vitamin D status are examined before and after supplementation
DIETARY_SUPPLEMENT	Enteral vitamin D supplementation of 400 IU/day	Standard recommended dose of enteral vitamin D supplementations (400 IU/day) are given for 28 days, and vitamin D status are examined before and after supplementation

Timeline

• Start date: 2024-07-17
• Primary completion: 2025-02-28
• Completion: 2025-03-10
• First posted: 2024-11-05
• Last updated: 2024-11-06

Locations

1 site across 1 country: Indonesia