Efficacy of Higher Dose Enteral Vitamin D Supplementation in Preterm 28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-17

Study Completion Date

2025-03-10

Brief Summary

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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

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Detailed Description

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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

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Vitamin D Supplementation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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400 IU

Participants will receive enteral vitamin D supplementation of 400 IU/day for 28 days

Group Type ACTIVE_COMPARATOR

Enteral vitamin D supplementation of 400 IU/day

Intervention Type DIETARY_SUPPLEMENT

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

800 IU

Participants will receive enteral vitamin D supplementation of 800 IU/day for 28 days

Group Type EXPERIMENTAL

Enteral vitamin D supplementation of 800 IU/day

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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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

Intervention Type 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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

28 Weeks

Maximum Eligible Age

34 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes