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Completed

NCT Number: NCT02941185

Multi-dose Vitamin D Supplementation in Preterm Infants

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.

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Key information

Age range

24 week–32 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Zekai Tahir Burak Women's Health and Education Hospital

Ankara, 06230, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Devit-3 Oral Drop

Drug

Primary outcomes

  1. Serum concentration of 25(OH) D at 36 weeks postmenstrual age.

    Time frame: 36 weeks

  2. Prevalence of vitamin D deficiency at 36 weeks postmenstrual age.

    Time frame: 36 weeks

Sponsors and collaborators

Lead sponsor

Zekai Tahir Burak Women's Health Research and Education Hospital

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 21, 2016
Registry last updated
Feb 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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