Palliative CareNCT06146452
Micronutrient Status in Pediatric Palliative Care
An observational study of Palliative Care and Micronutrients, run by Dr. Behcet Uz Children's Hospital at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to determine the micronutrient levels in patients in the Pediatric Palliative Care Clinic. The main question it aims to answer are: What is the frequency of micronutrient deficiencies in pediatric palliative care patients? Read more about this study
- Who is it for?
- Ages 1 month to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Palliative Care, Micronutrients, Pediatric
- What is being tested?
- Not
- How many people
- 249 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2023to 1 Oct 2024
- 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 1 month to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Our study will be carried out in the only pediatric palliative care center in Izmir that has been accepting patients since 2018. Our center is a clinic where palliative care patients (with chronic, complex, progressive or life-threatening diseases) between the ages of 1 month and 18 years who require hospitalization for various indications are managed with a multidisciplinary approach.
Who may be able to join
- Hospitalized in a pediatric palliative care service
Who cannot join
- Patients who are hospitalized without having chronic, complex, progressive or life-threatening diseases (for off-label reasons)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dr. Behcet Uz Children's Hospital
Izmir, 35150
About this study
Official title: Evaluation of Micronutrient Levels in Patients Hospitalized in the Pediatric Palliative Care Service.
The goal of this observational study is to determine the micronutrient levels in patients in the Pediatric Palliative Care Clinic. The main question it aims to answer are:
- What is the frequency of micronutrient deficiencies in pediatric palliative care patients?
Read the detailed description
Palliative care is an important health service provided with a multidisciplinary approach to improve the quality of life of children with progressive and life-threatening diseases and to manage symptoms effectively. This service aims to provide children with a good life experience by meeting the physical, psychological, social and spiritual needs of patients and their families.
Micronutrients contain important nutritional components such as vitamins, minerals and other nutrients that are essential for maintaining normal functions of the body. Micronutrient deficiencies affect at least half of children under five years of age. In a study conducted in pediatric oncology patients, micronutrient deficiency was shown to have a frequency of 74%, and selenium deficiency in particular negatively affected clinical outcomes. Contrary to recommended nutrient intakes (RNI) and expert opinion for healthy children, evidence-based recommendations for micronutrient requirements in critically ill children are not available. However, in pediatric palliative care, if the nutritional history indicates inadequate nutritional intake and/or growth indicates malnutrition, nutritional deficiencies that may have systemic effects, such as iron and vitamin B12 deficiency, need to be investigated.
This article aims to fill the gap in the literature by determining the micronutrient levels of pediatric palliative care patients hospitalized in the Pediatric Palliative Care Clinic. The research aims to contribute to a better understanding of the nutritional needs of patients in pediatric palliative care and to direct treatment approaches more effectively.
- Conditions
- Palliative Care, Micronutrients, Pediatric
- Being tested
- Not
- Keywords
- Pediatric, Palliative Care, micronutriens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NotOther
Not
| Study group | Role | What they receive |
|---|---|---|
| Pediatric palliative care | pediatric palliative care patients hospitalized in the Pediatric Palliative Care Clinic Receives: Other: Not |
What is being measured
The primary outcome is the main question the study is designed to answer.
the presence of micronutrient deficiency
Presence of micronutrient deficiency in patients hospitalized in pediatric palliative care clinic
Measured: 12/01/2023-01/01/2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study start1 Oct 2023
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Palliative CareStudies 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 only
- Time perspective
- Retrospective
- Enrolment
- 249 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Behcet Uz Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Derşan Onur, Dr. Behcet Uz Children's Hospital
- Investigators
- Derşan Onur, Principal investigator, Dr. Behcet Uz Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06146452
- Sponsor's protocol ID
- PPC Micronutrient
- Status last verified
- Apr 2024
- First submitted
- 19 Nov 2023
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Revuelta Iniesta R, Gerasimidis K, Paciarotti I, McKenzie JM, Brougham MF, Wilson DC. Micronutrient status influences clinical outcomes of paediatric cancer patients during treatment: A prospective cohort study. Clin Nutr. 2021 May;40(5):2923-2935. doi: 10.1016/j.clnu.2021.03.020. Epub 2021 Mar 20.
PubMed 33964502Marino LV, Valla FV, Beattie RM, Verbruggen SCAT. Micronutrient status during paediatric critical illness: A scoping review. Clin Nutr. 2020 Dec;39(12):3571-3593. doi: 10.1016/j.clnu.2020.04.015. Epub 2020 Apr 22.
PubMed 32371094Verbov J. More consultant dermatologists are needed. J R Coll Physicians Lond. 1990 Jul;24(3):249. No abstract available.
PubMed 2213683
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Micronutrient Levels in Patients Hospitalized in the Pediatric Palliative Care Service.
- ClinicalTrials.gov ID
- NCT06146452
- Acronym / sponsor ID
- PPC Micronutrient
- Conditions
- Palliative Care, Micronutrients, Pediatric
- Keywords
- Pediatric, Palliative Care, micronutriens
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 249 participants (estimated)
- Lead sponsor
- Dr. Behcet Uz Children's HospitalUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 24 Nov 2023 (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.
The goal of this observational study is to determine the micronutrient levels in patients in the Pediatric Palliative Care Clinic. The main question it aims to answer are:
- What is the frequency of micronutrient deficiencies in pediatric palliative care patients?
Detailed description
Palliative care is an important health service provided with a multidisciplinary approach to improve the quality of life of children with progressive and life-threatening diseases and to manage symptoms effectively. This service aims to provide children with a good life experience by meeting the physical, psychological, social and spiritual needs of patients and their families.
Micronutrients contain important nutritional components such as vitamins, minerals and other nutrients that are essential for maintaining normal functions of the body. Micronutrient deficiencies affect at least half of children under five years of age. In a study conducted in pediatric oncology patients, micronutrient deficiency was shown to have a frequency of 74%, and selenium deficiency in particular negatively affected clinical outcomes. Contrary to recommended nutrient intakes (RNI) and expert opinion for healthy children, evidence-based recommendations for micronutrient requirements in critically ill children are not available. However, in pediatric palliative care, if the nutritional history indicates inadequate nutritional intake and/or growth indicates malnutrition, nutritional deficiencies that may have systemic effects, such as iron and vitamin B12 deficiency, need to be investigated.
This article aims to fill the gap in the literature by determining the micronutrient levels of pediatric palliative care patients hospitalized in the Pediatric Palliative Care Clinic. The research aims to contribute to a better understanding of the nutritional needs of patients in pediatric palliative care and to direct treatment approaches more effectively.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric palliative care | – | Other: Notpediatric palliative care patients hospitalized in the Pediatric Palliative Care Clinic |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Our study will be carried out in the only pediatric palliative care center in Izmir that has been accepting patients since 2018. Our center is a clinic where palliative care patients (with chronic, complex, progressive or life-threatening diseases) between the ages of 1 month and 18 years who require hospitalization for various indications are managed with a multidisciplinary approach.
Key inclusion criteria (1 listed)
- Hospitalized in a pediatric palliative care service
Key exclusion criteria (1 listed)
- Patients who are hospitalized without having chronic, complex, progressive or life-threatening diseases (for off-label reasons)
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 |
|---|---|---|
| NotNot | Other | Pediatric palliative care |
Primary outcome
the presence of micronutrient deficiency
Time frame: 12/01/2023-01/01/2024
Presence of micronutrient deficiency in patients hospitalized in pediatric palliative care clinic
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- Results publication: PubMed 33964502Revuelta Iniesta R, Gerasimidis K, Paciarotti I, McKenzie JM, Brougham MF, Wilson DC. Micronutrient status influences clinical outcomes of paediatric cancer patients during treatment: A prospective cohort study. Clin Nutr. 2021 May;40(5):2923-2935. doi: 10.1016/j.clnu.2021.03.020. Epub 2021 Mar 20.
- Results publication: PubMed 32371094Marino LV, Valla FV, Beattie RM, Verbruggen SCAT. Micronutrient status during paediatric critical illness: A scoping review. Clin Nutr. 2020 Dec;39(12):3571-3593. doi: 10.1016/j.clnu.2020.04.015. Epub 2020 Apr 22.
- Results publication: PubMed 2213683Verbov J. More consultant dermatologists are needed. J R Coll Physicians Lond. 1990 Jul;24(3):249. No abstract available.
- Individual participant dataSharing planned: Undecided
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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.
Derşan Onur principal investigator
Dr. Behcet Uz Children's 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 Palliative Care and Micronutrients, run by Dr. Behcet Uz Children's 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 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: status not confirmed, as of the sponsor's last update on 25 Apr 2024. 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?
Results are not available in the source record.
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?
the presence of micronutrient deficiency (time frame: 12/01/2023-01/01/2024). 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 NCT06146452, which also lists 3 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 25 Apr 2024.