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Multi-dose Vitamin D Supplementation in Preterm Infants

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02941185
Enrollment
121
Registered
2016-10-21
Start date
2014-01-31
Completion date
2016-12-31
Last updated
2017-02-06

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

Conditions

Preterm Infants, Vitamin D Deficiency

Brief summary

Preterm newborns are born with lower vitamin D stores. Although vitamin D supplementation is recommended there is no consensus regarding the adequate dose of supplementation for preterm infants.

Detailed description

Vitamin D is a fat-soluble vitamin that is either taken by dietary sources or synthesized upon exposure to sun light. Although major function is on bone metabolism, in recent years other effects of Vitamin D attracted attention. Low neonatal vitamin D levels were reported to be associated with increased risk of respiratory distress syndrome (RDS), bronchopulmonary dysplasia (BPD) and sepsis. Vitamin D level in the fetus and the newborn is mostly dependent on maternal vitamin D levels. Most of the vitamin D is transferred to the fetus during third trimester and as a result preterm newborns especially those with \<32 weeks gestational age are born with lower vitamin D stores. But there is no consensus regarding the adequate dose of vitamin D supplementation for preterm infants. The American Academy of Pediatrics recommends supplementation of 200-400 IU/d vitamin D for preterm infants. And the European Society of Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) recommends 800-1000 IU/d vitamin D supplementation for preterm infants.

Interventions

DRUGDevit-3 Oral Drop

Sponsors

Zekai Tahir Burak Women's Health Research and Education Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
24 Weeks to 32 Weeks
Healthy volunteers
No

Inclusion criteria

* Preterm infants with gestational age 24 to 32 weeks who achieved at least 75% of total nutrition by enteral feedings in postnatal 2 weeks

Exclusion criteria

* perinatal asphyxia, * major congenital or chromosomal anomalies, * those with no expectation of survival in first 2 weeks * those that total parenteral nutrition was not ceased by the first 2 weeks

Design outcomes

Primary

MeasureTime frame
Serum concentration of 25(OH) D at 36 weeks postmenstrual age.36 weeks
Prevalence of vitamin D deficiency at 36 weeks postmenstrual age.36 weeks

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026