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

University of Indonesia (UI)

Status: Invitation-only

Conditions: Vitamin D Supplementation

Treatments: Dietary Supplement: Enteral vitamin D supplementation of 800 IU/day; Dietary Supplement: Enteral vitamin D supplementation of 400 IU/day

Study type: Interventional

Funder types: Other

Identifiers

NCT06674122

VitD800vs400

Details and patient eligibility

About

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

Full 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).

Enrollment: 54 estimated patients

Sex: All

Ages: 28 to 34 weeks old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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54 participants in 2 patient groups

400 IU

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Enteral vitamin D supplementation of 400 IU/day

800 IU

Experimental group

Description:

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

Treatment:

Dietary Supplement: Enteral vitamin D supplementation of 800 IU/day