NCT02941185

Multi-dose Vitamin D Supplementation in Preterm Infants

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital · Academic / Other
• Sex: All
• Age: 24 Weeks – 32 Weeks
• Healthy volunteers: Not accepted

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.

Conditions

• Vitamin D Deficiency
• Preterm Infants

Interventions

Type	Name	Description
DRUG	Devit-3 Oral Drop

Timeline

• Start date: 2014-01-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2016-10-21
• Last updated: 2017-02-06

Locations

1 site across 1 country: Turkey (Türkiye)