Vitamin D DeficiencyNCT02019836
Comparison of Maternal and Neonatal Vitamin D Levels in Term Neonates With and Without Early Onset Sepsis
An observational study of Vitamin D Deficiency, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Neonatal sepsis is a clinical syndrome characterized by signs and symptoms of infection with or without accompanying bacteremia in the first month of life which is still an important cause of morbidity and mortality. Read more about this study
- Who is it for?
- Ages Up to 72 hoursHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- Determining maternal and neonatal vitamin D levels
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2012to Jan 2013
- How long will I take part?
- 1 Year
- 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 Up to 72 hours
- All sexes
- Healthy volunteers accepted
- Child
Study population: Infants admitted to neonatal care unit with the diagnosis of high probable sepsis will constitute the sepsis group, whereas infants admitted to outpatient clinic without findings of sepsis will constitute the control group
Who may be able to join
- Infants >37 weeks of gestational age and are admitted to Neonatal Care Unit of Kanuni Sultan Suleyman Training and Research Hospital
- Infants with clinical and laboratory findings of early neonatal sepsis
- Term infants without sepsis as the control group
Who cannot join
- presence of maternal clinical and/or histological chorioamnionitis,
- presence of premature rupture of membranes (PROM),
- infants with probable or possible sepsis according to criteria,
- refusal of parental consent,
- lack of laboratory data,
- major congenital abnormalities
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kanuni Sultan Suleyman Training and Research Hospital
Istanbul
About this study
Neonatal sepsis is a clinical syndrome characterized by signs and symptoms of infection with or without accompanying bacteremia in the first month of life which is still an important cause of morbidity and mortality. Vitamin D is a fat-soluble steroid hormone that primarily contributes to the maintenance of normal calcium homeostasis and skeletal mineralization. In addition to its classical role in bone metabolism, vitamin D also has immunomodulatory effects on immune function. Although some studies reported a link between vitamin D deficiency and critical illness in adults, a direct relationship has not been directly shown yet. However, to the best of our knowledge, no study evaluated the association between EOS and maternal/neonatal vitamin D levels. The objective of this prospective study is to determine the possible role of maternal and neonatal plasma vitamin D levels on EOS development in term infants. We also aim to evaluate possible effect of the severity of vitamin D deficiency on EOS development in the study population.
Read the detailed description
Term infants with clinical and laboratory findings of early onset sepsis who are >37 weeks of gestational age and will be admitted to Neonatal Care Unit of Kanuni Sultan Suleyman Training and Research Hospital will be included in this prospective study. The study group will consist of term neonates who are clinically suspected to have an early infection from the 1st day of life. Blood for neonatal and maternal vitamin D levels will be obtained from all infants and their mothers at the time of hospital admission. Only infants with high probable sepsis will consist the study group. The healthy infants who admit to our outpatient clinic for routine evaluation at postnatal day 3 with no signs of clinical and laboratory infection and are evaluated for hyperbilirubinemia will be referred to as the Control group. The Control group wll consist term infants with the same gestational and postnatal age of the infants that will be included in the study group. In both groups, maternal samples will be obtained at the postpartum period at the time of infant's hospitalization. Plasmas after separated and stored at -800C. Levels of 25-OHD were determined using Shimadzu LC-20AT model High Performance Liquid Chromatography (HPLC) system. Data will be analyzed using SPSS software and appropriate statistical analyses will be performed.
- Conditions
- Vitamin D Deficiency
- Being tested
- Determining maternal and neonatal vitamin D levels
- Keywords
- vit D; sepsis; newborn; maternal; neonatal
- Medical subject headings
- Vitamin D Deficiency, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Determining maternal and neonatal vitamin D levelsOther
| Study group | Role | What they receive |
|---|---|---|
| sepsis group, control group | Sepsis group; infants with the diagnosis of high probable sepsis Control group; infants without sepsis Receives: Other: Determining maternal and neonatal vitamin D levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
development of early onset sepsis
A total of 100 infants will be included and vitamin D levels will be compared between those with and without neonatal sepsis
Measured: 1 year
Secondary outcomes (1)
severity of vitamin D deficiency and neonatal sepsis
Infants will be divided into three groups in terms of mild, moderate and severe vitamin D deficiency according to maternal and neonatal vitamin D levels and a possible association between vitamin D deficiency and culture proven sepsis will be investigated.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2013 (estimated)
- Study startMar 2012
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merih Cetinkaya, Kanuni Sultan Suleyman Training and Research Hospital
- Investigators
- Merih Cetinkaya, Study director, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02019836
- Sponsor's protocol ID
- MC10000
- Status last verified
- Dec 2013
- First submitted
- 18 Dec 2013
- Last updated
- 30 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gitto E, Karbownik M, Reiter RJ, Tan DX, Cuzzocrea S, Chiurazzi P, Cordaro S, Corona G, Trimarchi G, Barberi I. Effects of melatonin treatment in septic newborns. Pediatr Res. 2001 Dec;50(6):756-60. doi: 10.1203/00006450-200112000-00021.
PubMed 11726736Karatekin G, Kaya A, Salihoglu O, Balci H, Nuhoglu A. Association of subclinical vitamin D deficiency in newborns with acute lower respiratory infection and their mothers. Eur J Clin Nutr. 2009 Apr;63(4):473-7. doi: 10.1038/sj.ejcn.1602960. Epub 2007 Nov 21.
PubMed 18030309
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Maternal and Neonatal Vitamin D Levels in Term Neonates With and Without Early Onset Sepsis
- ClinicalTrials.gov ID
- NCT02019836
- Acronym / sponsor ID
- MC10000
- Conditions
- Vitamin D Deficiency
- Keywords
- vit D; sepsis; newborn; maternal; neonatal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 24 Dec 2013 (estimated)
- 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.
Neonatal sepsis is a clinical syndrome characterized by signs and symptoms of infection with or without accompanying bacteremia in the first month of life which is still an important cause of morbidity and mortality. Vitamin D is a fat-soluble steroid hormone that primarily contributes to the maintenance of normal calcium homeostasis and skeletal mineralization. In addition to its classical role in bone metabolism, vitamin D also has immunomodulatory effects on immune function. Although some studies reported a link between vitamin D deficiency and critical illness in adults, a direct relationship has not been directly shown yet. However, to the best of our knowledge, no study evaluated the association between EOS and maternal/neonatal vitamin D levels. The objective of this prospective study is to determine the possible role of maternal and neonatal plasma vitamin D levels on EOS development in term infants. We also aim to evaluate possible effect of the severity of vitamin D deficiency on EOS development in the study population.
Detailed description
Term infants with clinical and laboratory findings of early onset sepsis who are >37 weeks of gestational age and will be admitted to Neonatal Care Unit of Kanuni Sultan Suleyman Training and Research Hospital will be included in this prospective study. The study group will consist of term neonates who are clinically suspected to have an early infection from the 1st day of life. Blood for neonatal and maternal vitamin D levels will be obtained from all infants and their mothers at the time of hospital admission. Only infants with high probable sepsis will consist the study group. The healthy infants who admit to our outpatient clinic for routine evaluation at postnatal day 3 with no signs of clinical and laboratory infection and are evaluated for hyperbilirubinemia will be referred to as the Control group. The Control group wll consist term infants with the same gestational and postnatal age of the infants that will be included in the study group. In both groups, maternal samples will be obtained at the postpartum period at the time of infant's hospitalization. Plasmas after separated and stored at -800C. Levels of 25-OHD were determined using Shimadzu LC-20AT model High Performance Liquid Chromatography (HPLC) system. Data will be analyzed using SPSS software and appropriate statistical analyses will be performed.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sepsis group, control group | – | Other: Determining maternal and neonatal vitamin D levelsSepsis group; infants with the diagnosis of high probable sepsis Control group; infants without sepsis |
Who may qualify
- Ages
- Up to 72 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Infants admitted to neonatal care unit with the diagnosis of high probable sepsis will constitute the sepsis group, whereas infants admitted to outpatient clinic without findings of sepsis will constitute the control group
Key inclusion criteria (3 listed)
- Infants >37 weeks of gestational age and are admitted to Neonatal Care Unit of Kanuni Sultan Suleyman Training and Research Hospital
- Infants with clinical and laboratory findings of early neonatal sepsis
- Term infants without sepsis as the control group
Key exclusion criteria (6 listed)
- presence of maternal clinical and/or histological chorioamnionitis,
- presence of premature rupture of membranes (PROM),
- infants with probable or possible sepsis according to criteria,
- refusal of parental consent,
- lack of laboratory data,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Determining maternal and neonatal vitamin D levels | Other | sepsis group, control group |
Primary outcome
development of early onset sepsis
Time frame: 1 year
A total of 100 infants will be included and vitamin D levels will be compared between those with and without neonatal sepsis
1 secondary outcome
severity of vitamin D deficiency and neonatal sepsis
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2013.
- Background: PubMed 11726736Gitto E, Karbownik M, Reiter RJ, Tan DX, Cuzzocrea S, Chiurazzi P, Cordaro S, Corona G, Trimarchi G, Barberi I. Effects of melatonin treatment in septic newborns. Pediatr Res. 2001 Dec;50(6):756-60. doi: 10.1203/00006450-200112000-00021.
- Background: PubMed 18030309Karatekin G, Kaya A, Salihoglu O, Balci H, Nuhoglu A. Association of subclinical vitamin D deficiency in newborns with acute lower respiratory infection and their mothers. Eur J Clin Nutr. 2009 Apr;63(4):473-7. doi: 10.1038/sj.ejcn.1602960. Epub 2007 Nov 21.
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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.
Merih Cetinkaya study director
Kanuni Sultan Suleyman Training and Research Hospital
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 Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 30 Dec 2013. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
development of early onset sepsis (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02019836, which also lists 2 linked publications.
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 30 Dec 2013.