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

Neonatal Sepsis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02147327
• Other study ID #: sevit25D3
• Status: Completed
• Phase: N/A
• First received: May 21, 2014
• Last updated: May 27, 2014
• Start date: October 2013
• Est. completion date: May 2014

Study information

• Verified date: May 2014
• Source: Zekai Tahir Burak Women's Health Research and Education Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 30 Minutes

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypocalcemia
• Neonatal Hypocalcemia
• Neonatal Sepsis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zekai Tahir Burak Women's Health Research and Education Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sepsis		3 months but patients will be followed until discharge	No
Primary	feeding intolerance		3 months but patients will be followed until discharge	No
Primary	hypocalcemia		3 months but patients will be followed until discharge	No
Primary	bronchopulmonary dysplasia		3 months but patients will be followed until discharge	No
Primary	patent ductus arteriosis		3 months but patients will be followed until discharge	No
Primary	retinopathy of prematurity		3 months but patients will be followed until discharge	No
Primary	maternal complications of pregnancy		from the beginning of gestation until birth process	No
Secondary	rachitism		4 months but patients will be followed until discharge	No