CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 109 enrolled
Drug / intervention
monitored vit D supplementation +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

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NCT03087149N/ACompleted
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Supplementation of Vitamin D in Preterm Infants- Monitored Therapy vs Standard Therapy. A Randomized Controlled Trial

Princess Anna Mazowiecka Hospital, Warsaw, Poland·interventional·Posted Mar 22, 2017·Updated Feb 15, 2021

In Brief

A clinical study evaluating monitored vit D supplementation and standard vit D supplementation for Vitamin D Deficiency and 3 related conditions. Completed, enrolled 109 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVitamin D Deficiency, Osteopenia, Nephrolithiasis, Drug Overdose
CountriesPoland
CollaboratorsMedical University of Warsaw

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedMar 22, 2017
Enrollment StartMay 1, 2017
Primary CompletionDec 31, 2019
Study CompletionMar 31, 2020
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 9.3 years ago

Interventions

monitored vit D supplementationdietary

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.

standard vit D supplementationdietary

The vitamin D supplementation dose is 500IU from 7th day of age.