Vitamin A DeficiencyNCT04780958
Retinol Status in Preterm Infants and Mothers
A study testing Serum retinol and RBP levels were determined by enzyme-linked immunosorbent assay. in people with Vitamin A Deficiency, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
Retinol and retinol binding protein were studied in the umbilical cord blood of 44 preterm infants with gestation age of < 30 weeks. Serum retinol and RBP levels were determined by enzyme-linked immunosorbent assay. The rate of transplacental retinol passage was calculated. Read more about this study
- Who is it for?
- Ages 5 to 10 minutesHealthy volunteers can take part
- Conditions the study is for
- Vitamin A Deficiency
- What is being tested?
- Serum retinol and RBP levels were determined by enzyme-linked immunosorbent assay.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2020to 31 Jan 2021
- Phase
- Interventional
- 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 5 to 10 minutes
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Babies born l with a gestational week of <30 and their mothers were included in the study.
Who cannot join
- Patients were excluded in the presence of a major abnormality or known congenital metabolic disease in the mother or baby, and the presence of chronic liver, kidney or gastrointestinal system disease in the mother, or if the family did not give consent.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ataturk University Medical Faculty
Erzurum, 25100
About this study
Official title: The Effect of Retinol and RBP Levels of Cord Blood and Mothers on Mortality and Morbidity in Prematures With 30 Weeks and Lower
Retinol and retinol binding protein were studied in the umbilical cord blood of 44 preterm infants with gestation age of < 30 weeks. Serum retinol and RBP levels were determined by enzyme-linked immunosorbent assay. The rate of transplacental retinol passage was calculated. The demographic data of mother and baby, vitamin use in the mother, antenatal steroid application and diseases diagnosed during pregnancy were recorded. An evaluation was made of the retinol, RBP and factors of the mother and baby affecting the transplacental retinol passage. The relationship between retinol and retinol binding protein levels and neonatal mortality and morbidity was investigated.
Read the detailed description
Study Population Babies born at this hospital with a gestational week of <30 were included in the study. Patients were excluded in the presence of a major abnormality or known congenital metabolic disease in the mother or baby, and the presence of chronic liver, kidney or gastrointestinal system disease in the mother, or if the family did not give consent. A record was made of the gender and birth weight of the babies and gestation week, maternal age, gravidity, status of vitamin intake and use of vitamin A during pregnancy, and antenatal steroid administration in the mothers. A record was made of the presence of early membrane rupture (EMR) diagnosed during the present pregnancy of the mother, preeclampsia/eclampsia, pregnancy-induced hypertension, urinary infection, gestational diabetes mellitus and anemia, if present. We recorded also neonatal mortality and morbidity such as respiratory distress syndrome, retinopathy of prematurity, necrotizing enterocolitis, intraventricular hemorrhage, bronchopulmonary dysplasia,
Sampling and Test Study Method Umbilical cord blood was drawn at birth in all babies included in the study by experienced individuals using a vacutainer. Approximately 6 ml of venous blood was also drawn from the antecubital region of the mothers immediately after the birth in a biochemistry tube, and centrifuged for 10 minutes at 4500 rpm after the completion of coagulation, and the sera were separated. Serum samples were frozen and stored at -80° until the analysis was performed. For the analysis, serum samples were thawed in appropriate circumstances and all analyzes were performed at the Medical Biochemistry Laboratory of Atatürk University at a single session.
In the serum samples, the retinol levels were analyzed using ELISA kits from the Bioassay Technology Laboratory ( E1548 Hu Jiaxing, Zhejiang, China), RBP levels were analyzed using ELISA kits of Elabscience (E-EL-H1581 Texas USA) following the standard protocol suggested by the manufacturer at the Dynex automated ELISA reading device (Dynex Technologies Headquarters, Chantilly, USA). The measurement range of the kit for retinol and RBP was 2ng/ml- 800 ng/ml and 0,07 - 100 ng/mL, respectively.
The formula "umbilical cord retinol/maternal retinol x100" was used for the calculation of placental retinol passage rate in order to show the percentage of maternal retinol passing to the umbilical cord .
Retinol deficiency was evaluated according to the WHO data. A level of < 20 µg/dl was accepted as a deficiency. The level of deficiency was accepted as < 200 ng/ml since the unit used in this present study was ng/ml.
- Conditions
- Vitamin A Deficiency
- Being tested
- Serum retinol and RBP levels were determined by enzyme-linked immunosorbent assay.
- Keywords
- Retinol, Preterm infant, Morbidity, Placenta
- Medical subject headings
- Vitamin A Deficiency, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum retinol and RBP levels were determined by enzyme-linked immunosorbent assay.Other
Umbilical cord blood was drawn at birth in all babies included in the study by experienced individuals using a vacutainer. Approximately 6 ml of venous blood was also drawn from the antecubital region of the mothers immediately after the birth in a biochemistry tube.In the serum samples, the retinol levels were analyzed using ELISA kits from the Bioassay Technology Laboratory ( E1548 Hu Jiaxing, Zhejiang, China), RBP levels were analyzed using ELISA kits of Elabscience (E-EL-H1581 Texas USA) following the standard protocol suggested by the manufacturer at the Dynex automated ELISA reading device (Dynex Technologies Headquarters, Chantilly, USA)
| Study group | Role | What they receive |
|---|---|---|
| Study population | Other | During the study period, babies born at this hospital with a gestational week of <30 were included . Receives: Other: Serum retinol and RBP levels were determined by enzyme-linked immunosorbent assay. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinol deficiency status in preterm infants and mothers
Number of Participants with retinol deficiency was evaluated according to the WHO data. Concentration of retinol level < 20 µg/dl was accepted as a deficiency. The level of deficiency was accepted as < 200 ng/ml since the unit used in this present study was ng/ml.
Measured: 4 months
Retinol deficiency in preterm infants with respiratory distress syndrome
Numbers of preterm infants with respiratory distress syndrome as assessed accordingly European Consensus Respiratory Distress Syndrome, and have been reported retinol deficiency according to WHO data .
Measured: 3 months
Retinol deficiency in preterm infants with retinopathy of prematurity
Numbers of preterm infants with retinopathy of prematurity as assessed accordingly the International Classification of Retinopathy of Prematurity, and have been reported retinol deficiency according to WHO data .
Measured: 3 months
Retinol deficiency in preterm infants with bronchopulmonary dysplasia
Numbers of preterm infants with bronchopulmonary dysplasia as assessed accordingly the 2001 National Institutes of Health (NIH) Workshop, and have been reported retinol deficiency according to WHO data .
Measured: 3 months
Retinol deficiency in preterm infants with intraventricular hemorrhage
Numbers of preterm infants with intraventricular hemorrhage as assessed accordingly Grading System for Neonatal Intraventricular Hemorrhage, and have been reported retinol deficiency according to WHO data .
Measured: 3 months
Mortality of preterm infants
It was planned to check mortality rate in preterm infants with retinol deficiency. Retinol deficiency rate was calculated accordingly Who data.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start1 Jun 2020
- Primary completion31 Jan 2021
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin A DeficiencyStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kadir Şerafettin Tekgündüz, Ataturk University
- Investigators
- Kadir Ş Tekgündüz, Assoc.Prof, Study director, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04780958
- Sponsor's protocol ID
- TTU-2020-8630
- Status last verified
- Mar 2021
- First submitted
- 24 Feb 2021
- Last updated
- 5 Mar 2021
- 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 5 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Retinol and RBP Levels of Cord Blood and Mothers on Mortality and Morbidity in Prematures With 30 Weeks and Lower
- ClinicalTrials.gov ID
- NCT04780958
- Acronym / sponsor ID
- TTU-2020-8630
- Conditions
- Vitamin A Deficiency
- Keywords
- Retinol, Preterm infant, Morbidity, Placenta
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 4 Mar 2021 (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.
Retinol and retinol binding protein were studied in the umbilical cord blood of 44 preterm infants with gestation age of < 30 weeks. Serum retinol and RBP levels were determined by enzyme-linked immunosorbent assay. The rate of transplacental retinol passage was calculated. The demographic data of mother and baby, vitamin use in the mother, antenatal steroid application and diseases diagnosed during pregnancy were recorded. An evaluation was made of the retinol, RBP and factors of the mother and baby affecting the transplacental retinol passage. The relationship between retinol and retinol binding protein levels and neonatal mortality and morbidity was investigated.
Detailed description
Study Population Babies born at this hospital with a gestational week of <30 were included in the study. Patients were excluded in the presence of a major abnormality or known congenital metabolic disease in the mother or baby, and the presence of chronic liver, kidney or gastrointestinal system disease in the mother, or if the family did not give consent. A record was made of the gender and birth weight of the babies and gestation week, maternal age, gravidity, status of vitamin intake and use of vitamin A during pregnancy, and antenatal steroid administration in the mothers. A record was made of the presence of early membrane rupture (EMR) diagnosed during the present pregnancy of the mother, preeclampsia/eclampsia, pregnancy-induced hypertension, urinary infection, gestational diabetes mellitus and anemia, if present. We recorded also neonatal mortality and morbidity such as respiratory distress syndrome, retinopathy of prematurity, necrotizing enterocolitis, intraventricular hemorrhage, bronchopulmonary dysplasia,
Sampling and Test Study Method Umbilical cord blood was drawn at birth in all babies included in the study by experienced individuals using a vacutainer. Approximately 6 ml of venous blood was also drawn from the antecubital region of the mothers immediately after the birth in a biochemistry tube, and centrifuged for 10 minutes at 4500 rpm after the completion of coagulation, and the sera were separated. Serum samples were frozen and stored at -80° until the analysis was performed. For the analysis, serum samples were thawed in appropriate circumstances and all analyzes were performed at the Medical Biochemistry Laboratory of Atatürk University at a single session.
In the serum samples, the retinol levels were analyzed using ELISA kits from the Bioassay Technology Laboratory ( E1548 Hu Jiaxing, Zhejiang, China), RBP levels were analyzed using ELISA kits of Elabscience (E-EL-H1581 Texas USA) following the standard protocol suggested by the manufacturer at the Dynex automated ELISA reading device (Dynex Technologies Headquarters, Chantilly, USA). The measurement range of the kit for retinol and RBP was 2ng/ml- 800 ng/ml and 0,07 - 100 ng/mL, respectively.
The formula "umbilical cord retinol/maternal retinol x100" was used for the calculation of placental retinol passage rate in order to show the percentage of maternal retinol passing to the umbilical cord .
Retinol deficiency was evaluated according to the WHO data. A level of < 20 µg/dl was accepted as a deficiency. The level of deficiency was accepted as < 200 ng/ml since the unit used in this present study was ng/ml.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study population | Other | Other: Serum retinol and RBP levels were determined by enzyme-linked immunosorbent assay.During the study period, babies born at this hospital with a gestational week of <30 were included . |
Who may qualify
- Ages
- 5 to 10 minutes
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Babies born l with a gestational week of <30 and their mothers were included in the study.
Key exclusion criteria (1 listed)
- Patients were excluded in the presence of a major abnormality or known congenital metabolic disease in the mother or baby, and the presence of chronic liver, kidney or gastrointestinal system disease in the mother, or if the family did not give consent.
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 |
|---|---|---|
| Serum retinol and RBP levels were determined by enzyme-linked immunosorbent assay.Umbilical cord blood was drawn at birth in all babies included in the study by experienced individuals using a vacutainer. Approximately 6 ml of venous blood was also drawn from the antecubital region of the mothers immediately after the birth in a biochemistry tube.In the serum samples, the retinol levels were analyzed using ELISA kits from the Bioassay Technology Laboratory ( E1548 Hu Jiaxing, Zhejiang, China), RBP levels were analyzed using ELISA kits of Elabscience (E-EL-H1581 Texas USA) following the standard protocol suggested by the manufacturer at the Dynex automated ELISA reading device (Dynex Technologies Headquarters, Chantilly, USA) | Other | Study population |
Primary outcome
Retinol deficiency status in preterm infants and mothers
Time frame: 4 months
Number of Participants with retinol deficiency was evaluated according to the WHO data. Concentration of retinol level < 20 µg/dl was accepted as a deficiency. The level of deficiency was accepted as < 200 ng/ml since the unit used in this present study was ng/ml.
Retinol deficiency in preterm infants with respiratory distress syndrome
Time frame: 3 months
Numbers of preterm infants with respiratory distress syndrome as assessed accordingly European Consensus Respiratory Distress Syndrome, and have been reported retinol deficiency according to WHO data .
Retinol deficiency in preterm infants with retinopathy of prematurity
Time frame: 3 months
Numbers of preterm infants with retinopathy of prematurity as assessed accordingly the International Classification of Retinopathy of Prematurity, and have been reported retinol deficiency according to WHO data .
Retinol deficiency in preterm infants with bronchopulmonary dysplasia
Time frame: 3 months
Numbers of preterm infants with bronchopulmonary dysplasia as assessed accordingly the 2001 National Institutes of Health (NIH) Workshop, and have been reported retinol deficiency according to WHO data .
Retinol deficiency in preterm infants with intraventricular hemorrhage
Time frame: 3 months
Numbers of preterm infants with intraventricular hemorrhage as assessed accordingly Grading System for Neonatal Intraventricular Hemorrhage, and have been reported retinol deficiency according to WHO data .
Mortality of preterm infants
Time frame: 3 months
It was planned to check mortality rate in preterm infants with retinol deficiency. Retinol deficiency rate was calculated accordingly Who data.
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 5 Mar 2021.
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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.
Kadir Ş Tekgündüz, Assoc.Prof study director
Ataturk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serum retinol and RBP levels were determined by enzyme-linked immunosorbent assay. in people with Vitamin A Deficiency, run by Ataturk University 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 1 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: finished, as of the sponsor's last update on 5 Mar 2021. 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?
Retinol deficiency status in preterm infants and mothers (time frame: 4 months). The study lists 6 primary outcomes in all. 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 5 Mar 2021.