Trial | NCT03087149  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    vitamin d3 ...

  • Study Participants

    109
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.
Study Started
May 01
2017
Primary Completion
Dec 31
2019
Study Completion
Mar 31
2020
Last Update
Feb 15
2021

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.

monitored group Experimental

The monitored group will received monitored vit D supplementation

standard group Active Comparator

The standard group will receive standard vit D supplementation

Criteria 

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
No Results Posted