NCT06315452

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 11, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 18, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

March 18, 2024

Status Verified

March 1, 2024

Enrollment Period

2 years

First QC Date

March 11, 2024

Last Update Submit

March 11, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • vitamine D deficiency and maternal or feotal caracteristics

    6months

  • vitamine D deficiency and premature newborn comorbidities

    6 months

  • effect of supplementation

    6months

Eligibility Criteria

Age1 Day - 6 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

PREMATURE NEWBORN BORN BEFORE 32 WEEKS AND/OR WITH A BIRTH WEIGHT UNDER 1500g

You may qualify if:

  • 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.-

You may not qualify if:

  • \- Newborn whose parents or legal guardian refuse the use of their data for this research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Saint Joseph

Paris, 75014, France

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2024

First Posted

March 18, 2024

Study Start

February 1, 2022

Primary Completion

February 1, 2024

Study Completion

June 1, 2024

Last Updated

March 18, 2024

Record last verified: 2024-03

Locations