Monitored vs Standard Supplementation of Vitamin D in Preterm Infants — MOSVID  

Vitamin D Deficiency Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Bone Diseases, Metabolic
• Drug Overdose
• Kidney Calculi
• Nephrolithiasis
• Osteopenia
• Vitamin D Deficiency

• NCT number: NCT03087149
• Study type: Interventional
• Source: Princess Anna Mazowiecka Hospital, Warsaw, Poland
• Status: Completed
• Phase: N/A
• Start date: May 1, 2017
• Completion date: March 31, 2020