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Monitored vs Standard Supplementation of Vitamin D in Preterm Infants

NCT03087149 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 109

Last updated 2021-02-15

No results posted yet for this study

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.

Conditions

  • Vitamin D Deficiency
  • Osteopenia
  • Nephrolithiasis
  • Drug Overdose

Interventions

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.

Sponsors & Collaborators

  • Medical University of Warsaw

    collaborator OTHER

  • Princess Anna Mazowiecka Hospital, Warsaw, Poland

    lead OTHER

Principal Investigators

  • Maria K Borszewska-Kornacka, Professor · Princess Anna Mazowiecka Hospital

  • Renata Bokiniec, M.D. · Princess Anna Mazowiecka Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
7 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-01
Primary Completion
2019-12-31
Completion
2020-03-31

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03087149 on ClinicalTrials.gov