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NCT06315452 Clinical Trial

FREQUENCY OF VITAMIN D DEFICIENCY IN PREMATURE NEWBORN BORN BEFORE 32 WEEKS AND/OR WITH A BIRTH WEIGHT UNDER 1500g

Vitamin D Deficiency Clinical Trial

— PremaVitaD  

Official title:
FREQUENCY OF VITAMIN D DEFICIENCY IN PREMATURE NEWBORN BORN BEFORE 32 WEEKS AND/OR WITH A BIRTH WEIGHT UNDER 1500g

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT06315452
Other study ID # PremaVitaD
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date February 1, 2022
Est. completion date June 1, 2024

Study information
Verified date March 2024
Source Fondation Hôpital Saint-Joseph
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Vitamin D plays an important role in phosphocalcic metabolism and bone homeostasis in newborns. Premature newborns are at risk of vitamin D deficiency and may require supplementation. In this context, the French Society of Pediatrics (Société Française de Pédiatrie) recommends systematic vitamin D testing at 1 month. The aim of this study was to determine the frequency of vitamin D deficiency in premature newborns.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 110
Est. completion date June 1, 2024
Est. primary completion date February 1, 2024
Accepts healthy volunteers No
Gender All
Age group 1 Day to 6 Months
Eligibility Inclusion Criteria: - Premature newborns born at a gestational age less than 32 weeks and/or birth weight less than 1500g - Having received at least one dosage of 25 OH vitamin D.- Exclusion Criteria: - - Newborn whose parents or legal guardian refuse the use of their data for this research

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Hôpital Saint Joseph Paris

Sponsors (1)
Lead Sponsor Collaborator
Fondation Hôpital Saint-Joseph

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Vitamine D deficiency frequency 25-OH Vitamine D values will be collected for premature newborn , born before 32 weeks, or with a birth weight under 1500g.
A 25-OH Vitamine D blood value under 20µg/L is considered as a vitamine D deficiency		 6 months
Secondary vitamine D deficiency and maternal or feotal caracteristics correlation between vitamine D deficiency and maternal or feotal caracteristics 6months
Secondary vitamine D deficiency and premature newborn comorbidities correlation between vitamine D deficiency and premature newborn comorbidities 6 months
Secondary effect of supplementation Number (proportion) of children with normalized 25 OH vitamin D levels after Vitamine D supplementation according to neonatal department protocol. 6months
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