An interventional study of Enteral vitamin D supplementation of 800 IU/day and Enteral vitamin D supplementation of 400 IU/day in Vitamin D Supplementation, sponsored by Indonesia University. Enrolling by invitation at 1 site in Indonesia. Open to participants aged 28 Weeks to 34 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-06.
Sponsored by Indonesia University · Not applicable, Interventional, and Supportive care
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:
Participants will:
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).
2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.
This study's planned enrollment of 54 is below the median of 84 across 1,689 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →Indonesia University is the lead sponsor of 448 studies on the registry; 56 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive enteral vitamin D supplementation of 400 IU/day for 28 days
Dietary Supplement: Enteral vitamin D supplementation of 400 IU/day
Participants will receive enteral vitamin D supplementation of 800 IU/day for 28 days
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
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
25(OH)D level
serum level of 25(OH)D
Time frame: From enrollment to the end of treatment at 4 weeks
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Indonesia University