Vitamin D DeficiencyPremaVitaDNCT06315452
FREQUENCY OF VITAMIN D DEFICIENCY IN PREMATURE NEWBORN BORN BEFORE 32 WEEKS AND/OR WITH A BIRTH WEIGHT UNDER 1500g
An observational study of Vitamin D Deficiency, run by Fondation Hôpital Saint-Joseph at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 1 day to 6 months
- Conditions the study is for
- Vitamin D Deficiency
- How many people
- 110 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2022to 1 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 6 months
- All sexes
- No healthy volunteers
- Child
Study population: PREMATURE NEWBORN BORN BEFORE 32 WEEKS AND/OR WITH A BIRTH WEIGHT UNDER 1500g
Who may be able to join
- 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.-
Who cannot join
- - Newborn whose parents or legal guardian refuse the use of their data for this research
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Vitamin D Deficiency
- Medical subject headings
- Vitamin D Deficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (3)
vitamine D deficiency and maternal or feotal caracteristics
correlation between vitamine D deficiency and maternal or feotal caracteristics
Measured: 6months
vitamine D deficiency and premature newborn comorbidities
correlation between vitamine D deficiency and premature newborn comorbidities
Measured: 6 months
effect of supplementation
Number (proportion) of children with normalized 25 OH vitamin D levels after Vitamine D supplementation according to neonatal department protocol.
Measured: 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start1 Feb 2022
- Primary completion1 Feb 2024
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06315452
- Sponsor's protocol ID
- PremaVitaD
- Acronym
- PremaVitaD
- Status last verified
- Mar 2024
- First submitted
- 11 Mar 2024
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FREQUENCY OF VITAMIN D DEFICIENCY IN PREMATURE NEWBORN BORN BEFORE 32 WEEKS AND/OR WITH A BIRTH WEIGHT UNDER 1500g
- ClinicalTrials.gov ID
- NCT06315452
- Acronym / sponsor ID
- PremaVitaD / PremaVitaD
- Conditions
- Vitamin D Deficiency
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 18 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 day to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- PREMATURE NEWBORN BORN BEFORE 32 WEEKS AND/OR WITH A BIRTH WEIGHT UNDER 1500g
Key inclusion criteria (2 listed)
- 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.-
Key exclusion criteria (1 listed)
- - Newborn whose parents or legal guardian refuse the use of their data for this research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Vitamine D deficiency frequency
Time frame: 6 months
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
3 secondary outcomes
vitamine D deficiency and maternal or feotal caracteristics
Time frame: 6months
vitamine D deficiency and premature newborn comorbidities
Time frame: 6 months
effect of supplementation
Time frame: 6months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitamin D Deficiency, run by Fondation Hôpital Saint-Joseph at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vitamine D deficiency frequency (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024.