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
• Status: Active, not recruiting
• 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
• 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

Related Conditions & MeSH terms

• Birth Weight
• Premature Birth
• Vitamin D Deficiency

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