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
Lead SponsorPrincess Anna Mazowiecka Hospital
StatusCompleted No Results Posted
Intervention/Treatmentvitamin d3 ...
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.
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.
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.
The vitamin D supplementation dose is 500IU from 7th day of age.
Inclusion Criteria: Preterm infants born between 24 and 32 weeks of gestation (estimated by ultrasound) In born or admitted to the unit within 48hours from birth. Randomization within 7 days from birth. Parental consent. Mothers willing to return for follow up visits. Exclusion Criteria: Preterm delivery >=33 weeks of gestation or term delivery (estimated by ultrasound). Major congenital abnormalities. Participation in another trial. Severe illness at birth deemed incompatible with survival. Congenital HIV infection. Total parenteral nutrition > 14 days. Cholestasis