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
1 other identifier
interventional
54
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 17, 2024
CompletedFirst Submitted
Initial submission to the registry
November 1, 2024
CompletedFirst Posted
Study publicly available on registry
November 5, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 10, 2025
CompletedNovember 6, 2024
November 1, 2024
8 months
November 1, 2024
November 4, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
25(OH)D level
serum level of 25(OH)D
From enrollment to the end of treatment at 4 weeks
Study Arms (2)
400 IU
ACTIVE COMPARATORParticipants will receive enteral vitamin D supplementation of 400 IU/day for 28 days
800 IU
EXPERIMENTALParticipants will receive enteral vitamin D supplementation of 800 IU/day for 28 days
Interventions
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
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
Eligibility Criteria
You may qualify if:
- neonates with gestational age 28-34 weeks
- tolerated enteral feedings more than 30ml/kg
You may not qualify if:
- infants with major congenital anomaly
- infants with gastrointestinal obstruction
- infants with congenital renal failure
- infants with cholestassis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cipto Mangunkusumo Hospital
Jakarta, Central Jakarta, 10430, Indonesia
Study Officials
- PRINCIPAL INVESTIGATOR
Rosalina D Roeslani, dr, SpA(K)
FKUI RSCM
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Neonatology Division, Principal Investigator
Study Record Dates
First Submitted
November 1, 2024
First Posted
November 5, 2024
Study Start
July 17, 2024
Primary Completion
February 28, 2025
Study Completion
March 10, 2025
Last Updated
November 6, 2024
Record last verified: 2024-11