NCT03087149

Monitored vs Standard Supplementation of Vitamin D in Preterm Infants

Supplementation of Vitamin D in Preterm Infants- Monitored Therapy vs Standard Therapy. A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 109 (actual)
• Sponsor: Princess Anna Mazowiecka Hospital, Warsaw, Poland · Academic / Other
• Sex: All
• Age: 1 Day – 7 Days
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine wheather the monitored vitamin D (vit D) therapy is safer and more effective than standard therapy in pretrem infants.

Detailed description

Vitamin D (vit D) deficiency is a risk factor of osteopenia of prematurity, which leads to rickets or decreased bone mass mineral density. Recently multiple studies have been published on vit D adjust biological functions. Dosage, safety and effectiveness of vitD supplementation in preterm infants still remains a controversial topic. We hypothesize that monitored supplementation of vit D is more effective and safer than standard therapy 500IU in preterm infants. The study will be carried out in 138 preterm infants, born at 24-32 week of gestational age (GA) at the Princess Anne's Hospital in Warsaw, Poland. We will determine if monitored supplementation of vit D decreases the incidence of vit D deficiency and/or overdosing at 40 week (GA). For secondary objective we shall assess if monitored therapy reduces the incidence of vit D deficiency and/or overdosing at 35, 52 week (GA), prevalence of osteopenia, low bone mass, nephrocalcinosis and nephrolithiasis.

Conditions

• Vitamin D Deficiency
• Osteopenia
• Nephrolithiasis
• Drug Overdose

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	monitored vit D supplementation	The vit D supplementation dose start from dose 500IU from 7th day of age and is modified based on vit D measurement at 4 week of age for infants born \<30 GA, at 8 week of age for infants born \<26 GA at 35+/-2 weeks PMA(postmenstrual age), +/-at 40+/-2 weeks PMA according to the protocol.
DIETARY_SUPPLEMENT	standard vit D supplementation	The vitamin D supplementation dose is 500IU from 7th day of age.

Timeline

• Start date: 2017-05-01
• Primary completion: 2019-12-31
• Completion: 2020-03-31
• First posted: 2017-03-22
• Last updated: 2021-02-15

Locations

1 site across 1 country: Poland