Cord Blood 25(oh)-Vitamin D Level in Preterm Infants and Associated Morbidities

NCT ID: NCT01812681

Last Updated: 2014-08-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

81 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Experimental and observational studies have shown that vitamin D deficiency may be associated with an increased risk for non-bone diseases and/or abnormal development for the other systems of fetus. The aim of this study is to determine the relationship between cord blood 25-hydroxyvitamin D (25 (OH) D) concentrations and the subsequent risk of morbidities including RDS, PDA, NEC, BPD AND ROP in preterm infants.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

It was shown that vitamin D play important role in the pathogenesis of long term morbidities of newborn. Experimental and observational studies have shown that vitamin D deficiency may be associated with an increased risk for non-bone diseases and/or abnormal development for the other systems of fetus. The aim of this study is to determine the relationship between cord blood 25-hydroxyvitamin D (25 (OH) D) concentrations and the subsequent risk of morbidities including RDS, PDA, NEC, BPD AND ROP in preterm infants.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Respiratory Distress Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Low vitamin D level

The premature infants with low cord blood vitamin D level

No interventions assigned to this group

Normal Vitamin D

The premature infants with normal vitamin D level

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* infants \<32 weeks of gestational age

Exclusion Criteria

* infants with major congenital abnormality
* infants \>32 weeks of gestational age
Minimum Eligible Age

1 Day

Maximum Eligible Age

5 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Dr. Sami Ulus Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Serdar Beken

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Dilek Dilli, Assoc Prof

Role: STUDY_DIRECTOR

Sami Ulus CH

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sami Ulus CH

Ankara, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

Grant WB. Vitamin D supplementation of mother and infant could reduce risk of sepsis in premature infants. Early Hum Dev. 2010 Feb;86(2):133. doi: 10.1016/j.earlhumdev.2010.02.003. Epub 2010 Feb 25. No abstract available.

Reference Type BACKGROUND
PMID: 20188500 (View on PubMed)

Fettah ND, Zenciroglu A, Dilli D, Beken S, Okumus N. Is higher 25-hydroxyvitamin D level preventive for respiratory distress syndrome in preterm infants? Am J Perinatol. 2015 Feb;32(3):247-50. doi: 10.1055/s-0034-1383849. Epub 2014 Sep 13.

Reference Type DERIVED
PMID: 25217734 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

B.10.4.İSM.4.06.68.49

Identifier Type: OTHER

Identifier Source: secondary_id

B.10.4.İSM.4.06.68.49

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Prevention of Vitamin D Deficiency
NCT00494104 COMPLETED NA
Vitamin D Supplementation in Breastfeeding Women
NCT01240265 COMPLETED PHASE2/PHASE3
ViDES Trial (Vitamin D Extra Supplementation)
NCT05459298 ACTIVE_NOT_RECRUITING NA