Multi-dose Vitamin D Supplementation in Preterm Infants

Vitamin D Deficiency Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02941185
• Other study ID #: ZTB2015
• Status: Completed
• Phase: Phase 4
• First received: October 18, 2016
• Last updated: February 3, 2017
• Start date: January 2014
• Est. completion date: December 2016

Study information

• Verified date: February 2017
• Source: Zekai Tahir Burak Women's Health Research and Education Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 24 Weeks to 32 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Preterm Infants
• Vitamin D Deficiency

Intervention

Drug:
• Devit-3 Oral Drop

Locations

Country	Name	City	State
Turkey	Zekai Tahir Burak Women's Health and Education Hospital	Ankara

Sponsors (1)

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

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum concentration of 25(OH) D at 36 weeks postmenstrual age.		36 weeks
Primary	Prevalence of vitamin D deficiency at 36 weeks postmenstrual age.		36 weeks