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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06674122
Enrollment
54
Registered
2024-11-05
Start date
2024-07-17
Completion date
2025-03-10
Last updated
2024-11-06

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

Conditions

Vitamin D Supplementation

Keywords

vitamin D supplementation in preterm

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

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).

Interventions

DIETARY_SUPPLEMENTEnteral 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_SUPPLEMENTEnteral 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

Sponsors

Indonesia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
28 Weeks to 34 Weeks
Healthy volunteers
Yes

Inclusion criteria

* neonates with gestational age 28-34 weeks * tolerated enteral feedings more than 30ml/kg

Exclusion criteria

* infants with major congenital anomaly * infants with gastrointestinal obstruction * infants with congenital renal failure * infants with cholestassis

Design outcomes

Primary

MeasureTime frameDescription
25(OH)D levelFrom enrollment to the end of treatment at 4 weeksserum level of 25(OH)D

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026