Effects of Cord Blood 25-hydroxy-vitamin D Level on Early Neonatal Morbidities

May 27, 2014 updated by: birgul say, Zekai Tahir Burak Women's Health Research and Education Hospital
Cholecalciferol (vitamin D3) is a prohormone and its active form is 1,25 dihydroxycholecalciferol. This hormone has effect on both calcium, phosphorus and bone metabolism and also bone morrow, muscle, heart and immune system. For a long time, maternal low vitamin D level is a well known problem for our country and the level was reported as <10 ng/ml for 46-80% of mothers.The most prominent risk factor was determined as low socioeconomic status. Therefore, the level of 25-hydroxy-vitamin D is supposed to be in relation with several neonatal morbidities and maternal complications of pregnancy.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

120

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 30 minutes (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Newborns which are hospitalized in the Neonatal Intensive Care Unit of our hospital

Description

Inclusion Criteria:

  • Term or preterm newborns which are hospitalized in the Neonatal Intensive Care Unit of our hospital

Exclusion Criteria:

  • Preterm babies born before the 24. gestational week
  • Babies with complex cardiac anomalies and/or dysmorphic features

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
sepsis
Time Frame: 3 months but patients will be followed until discharge
3 months but patients will be followed until discharge
feeding intolerance
Time Frame: 3 months but patients will be followed until discharge
3 months but patients will be followed until discharge
hypocalcemia
Time Frame: 3 months but patients will be followed until discharge
3 months but patients will be followed until discharge
bronchopulmonary dysplasia
Time Frame: 3 months but patients will be followed until discharge
3 months but patients will be followed until discharge
patent ductus arteriosis
Time Frame: 3 months but patients will be followed until discharge
3 months but patients will be followed until discharge
retinopathy of prematurity
Time Frame: 3 months but patients will be followed until discharge
3 months but patients will be followed until discharge
maternal complications of pregnancy
Time Frame: from the beginning of gestation until birth process
from the beginning of gestation until birth process

Secondary Outcome Measures

Outcome Measure
Time Frame
rachitism
Time Frame: 4 months but patients will be followed until discharge
4 months but patients will be followed until discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zekai Tahir Burak Women's Health Research and Education Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

May 21, 2014

First Submitted That Met QC Criteria

May 21, 2014

First Posted (Estimate)

May 26, 2014

Study Record Updates

Last Update Posted (Estimate)

May 29, 2014

Last Update Submitted That Met QC Criteria

May 27, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • sevit25D3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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