Respiratory DiseasePhase 4NCT06926712
The Effect of Vitamin E Supplementation on Hospital Stay Duration in Non-cyanotic Heart Disease Children With Lower Respiratory Tract Infections
A Phase 4 study testing Vitamin E in people with Respiratory Disease, run by Assiut University.
Trial summary
Congenital heart disease can lead to serious health issues, particularly an increased risk of infections, specifically respiratory infections. Lower respiratory tract infections are the fifth leading cause of death globally. Read more about this study
- Who is it for?
- Ages 2 months to 5 years
- Conditions the study is for
- Respiratory Disease
- What is being tested?
- Vitamin E
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- No sites listed yet
- Study dates
- Jun 2025to Jun 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 2 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients are diagnosed with non-cyanotic heart disease associated with severe lower respiratory tract infection. ⁃ The patients are aged 2 months to 5 years of both sexes.
Who cannot join
- Pediatric patients that have other congenital anomalies other than CHD.
- Those with chronic respiratory diseases such as asthma, bronchiectasis, etc.).
- Immunocompromised patients, such as those who receive steroids or chemotherapy, etc.
- Pediatric patient that received vitamin E in the previous month.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Vitamin E Supplementation on Hospital Stay Duration in Non-cyanotic Heart Disease Children With Lower Respiratory Tract Infections - Randomized Controlled Trial
Congenital heart disease can lead to serious health issues, particularly an increased risk of infections, specifically respiratory infections. Lower respiratory tract infections are the fifth leading cause of death globally. Also considered a significant cause of morbidity and mortality among children with congenital heart disease.
In Egypt, it is estimated that 10% of deaths in children under the age of 5 years are probably caused by lower respiratory tract infections and other acute respiratory infections. common non-cyanotic CHD like Ventricular septal defect predispose to bronchopneumonia.
Read more
Hemodynamically significant congenital heart disease with pulmonary congestion increases the risk of lower respiratory tract infections and hospitalizations. This relies on several modifiable risk factors, including low socioeconomic status, poor diet, overcrowding, prematurity, male gender, and exposure to secondhand smoke.
Micronutrients play a crucial role in strengthening the immune system. Many Studies have shown that when children are supplemented with various micronutrients, they experience fewer episodes of acute respiratory infections, and the duration and severity of these infections are reduced.
Vitamin E is essential for immune system function and may lower disease risk by enhancing immune responses. It protects neurons and respiratory mucosa from oxidative damage and has been linked to a reduced incidence of asthma and inflammation, potentially safeguarding young children from atopy and wheezing.
There are no available studies in our locality about the effect of vitamin E supplementation on the length of hospital stay for non-cyanotic cardiac patients with lower respiratory tract infections.
Read the detailed description
Congenital heart disease can lead to serious health issues, particularly an increased risk of infections, specifically respiratory infections. Lower respiratory tract infections are the fifth leading cause of death globally. Also considered a significant cause of morbidity and mortality among children with congenital heart disease.
In Egypt, it is estimated that 10% of deaths in children under the age of 5 years are probably caused by lower respiratory tract infections and other acute respiratory infections. common non-cyanotic CHD like Ventricular septal defect predispose to bronchopneumonia.
Hemodynamically significant congenital heart disease with pulmonary congestion increases the risk of lower respiratory tract infections and hospitalizations. This relies on several modifiable risk factors, including low socioeconomic status, poor diet, overcrowding, prematurity, male gender, and exposure to secondhand smoke.
Micronutrients play a crucial role in strengthening the immune system. Many Studies have shown that when children are supplemented with various micronutrients, they experience fewer episodes of acute respiratory infections, and the duration and severity of these infections are reduced.
Vitamin E is essential for immune system function and may lower disease risk by enhancing immune responses. It protects neurons and respiratory mucosa from oxidative damage and has been linked to a reduced incidence of asthma and inflammation, potentially safeguarding young children from atopy and wheezing.
There are no available studies in our locality about the effect of vitamin E supplementation on the length of hospital stay for non-cyanotic cardiac patients with lower respiratory tract infections.
- Conditions
- Respiratory Disease
- Being tested
- Vitamin E
- Keywords
- RTI-VIT E- CHD
- Medical subject headings
- Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin EDrug
dose of vitamin E in an appropriate dose for age during hospital stay for intervention group
| Study group | Role | What they receive |
|---|---|---|
| intervention | Active comparator | The intervention group will receive vitamin E in an appropriate dose during the hospital stay with the treatment protocol for chest infection Receives: Drug: Vitamin E |
| control group | No intervention | The control group will receive the treatment protocol for chest infection only or with placebo instead of vitamin E. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the length of hospital stay
The effect of vitamin E supplementation on the length of hospital stay in non-cyanotic cardiac pediatric patients with lower respiratory tract infections.
Measured: During the intervention
Secondary outcomes (1)
risk factors
To assess the impact of identified risk factors (e.g., prematurity, malnutrition, severity of pneumonia, and different age groups) on hospital length of stay.
- To determine the incidence of complications (e.g., need for ICU, mechanical ventilation, congestive heart failure) concerning identified risk factors.
Measured: During the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study startJun 2025 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Safaa Ahmed Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06926712
- Sponsor's protocol ID
- safaa1451995protocol
- Status last verified
- Apr 2025
- First submitted
- 12 Mar 2025
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
[1] M. M. Djer and D. B. S. , Emilda Osmardin, Badriul Hegar, "Increased Risk of Recurrent Acute Respiratory Infections in Children with Congenital Heart Disease: A Prospective Cohort Study," Indones. Biomed. J., vol. 12, no. 4, p. p.288-389, 2020, doi: 10.18585/inabj.v12i4.1262. [2] E. Kılıçoğlu and Z. Ü. Tutar, "Evaluation of Children with Congenital Heart Disease Hospitalized with the Diagnosis of Lower Respiratory Tract Infection," J. Pediatr. Res., vol. 5, no. July 2017, pp. 32-36, 2018. [3] Z. Chen, "Circulating micronutrient levels and respiratory infection susceptibility and severity : a bidirectional Mendelian randomization analysis," no. August, 2024, doi: 10.3389/fnut.2024.1373179. [4] A. M. M. Hamed, Y. T. Kassem, H. K. Fayed, and A. M. Solaiman, "Serum zinc levels in hospitalized children with pneumonia: a hospital-based case-control study," Egypt. J. Bronchol., vol. 13, no. 5, pp. 730-737, 2019, doi: 10.4103/ejb.ejb_30_19. [5] N. K. Jat, D. K. Bhagwani, N. Bhutani, U. Sharma, R. Sharma, and R. Gupta, "Assessment of the prevalence of congenital heart disease in children with pneumonia in tertiary care hospital : A cross-sectional study," Ann. Med. Surg., vol. 73, no. November 2021, p. 103111, 2022, doi: 10.1016/j.amsu.2021.103111. [6] O. Investigation, "The Role of the Micronutrients; Vitamin A, Vitamin B12, Iron, Zinc, Copper Levels of Children with Lower Respiratory Tract Infections," pp. 105-109, 2005, doi: 10.5152/ced.2014.1319. [7] M. X. Wang, J. Koh, and J. Pang, "Association between micronutrient deficiency and acute respiratory infections in healthy adults : a systematic review of observational studies," pp. 1-12, 2019. [8] P. C. Calder and P. Yaqoob, "Nutrient Regulation of the Immune Response," Present Knowl. Nutr. Tenth Ed., no. January, pp. 688-708, 2012, doi: 10.1002/9781119946045.ch44. [9] S. Wu and A. Wang, "Serum level and clinical significance of vitamin E in pregnant women with allergic rhinitis," J. Chinese Med. Assoc., vol. 85, no. 5, pp. 597-602, 2022, doi: 10.1097/JCMA.0000000000000723. [10] S. I. Fahmy, L. M. Nofal, S. F. Shehata, H. M. El, and H. K. Ibrahim, "Updating indicators for scaling the socioeconomic level of families for health research," pp. 1-7, 2015, doi: 10.1097/01.EPX.0000461924.05829.93. [11] J. Thokngaen and W. Karoonboonyanan, "Pediatric respiratory severity score evaluates disease severity of respiratory tract infection in children," Chulalongkorn Med. J., vol. 63, no. 1, pp. 41-46, 2019, doi: 10.14456/clmj.1476.6. [12] T. Bohn et al., "Scientific opinion on the tolerable upper intake level for vitamin E," vol. 22, pp. 1-104, 2024, doi: 10.2903/j.efsa.2024.8953.
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vitamin E Supplementation on Hospital Stay Duration in Non-cyanotic Heart Disease Children With Lower Respiratory Tract Infections - Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06926712
- Acronym / sponsor ID
- safaa1451995protocol
- Conditions
- Respiratory Disease
- Keywords
- RTI-VIT E- CHD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jun 2025 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 15 Apr 2025 (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.
Congenital heart disease can lead to serious health issues, particularly an increased risk of infections, specifically respiratory infections. Lower respiratory tract infections are the fifth leading cause of death globally. Also considered a significant cause of morbidity and mortality among children with congenital heart disease.
In Egypt, it is estimated that 10% of deaths in children under the age of 5 years are probably caused by lower respiratory tract infections and other acute respiratory infections. common non-cyanotic CHD like Ventricular septal defect predispose to bronchopneumonia.
Hemodynamically significant congenital heart disease with pulmonary congestion increases the risk of lower respiratory tract infections and hospitalizations. This relies on several modifiable risk factors, including low socioeconomic status, poor diet, overcrowding, prematurity, male gender, and exposure to secondhand smoke.
Micronutrients play a crucial role in strengthening the immune system. Many Studies have shown that when children are supplemented with various micronutrients, they experience fewer episodes of acute respiratory infections, and the duration and severity of these infections are reduced.
Vitamin E is essential for immune system function and may lower disease risk by enhancing immune responses. It protects neurons and respiratory mucosa from oxidative damage and has been linked to a reduced incidence of asthma and inflammation, potentially safeguarding young children from atopy and wheezing.
There are no available studies in our locality about the effect of vitamin E supplementation on the length of hospital stay for non-cyanotic cardiac patients with lower respiratory tract infections.
Detailed description
Congenital heart disease can lead to serious health issues, particularly an increased risk of infections, specifically respiratory infections. Lower respiratory tract infections are the fifth leading cause of death globally. Also considered a significant cause of morbidity and mortality among children with congenital heart disease.
In Egypt, it is estimated that 10% of deaths in children under the age of 5 years are probably caused by lower respiratory tract infections and other acute respiratory infections. common non-cyanotic CHD like Ventricular septal defect predispose to bronchopneumonia.
Hemodynamically significant congenital heart disease with pulmonary congestion increases the risk of lower respiratory tract infections and hospitalizations. This relies on several modifiable risk factors, including low socioeconomic status, poor diet, overcrowding, prematurity, male gender, and exposure to secondhand smoke.
Micronutrients play a crucial role in strengthening the immune system. Many Studies have shown that when children are supplemented with various micronutrients, they experience fewer episodes of acute respiratory infections, and the duration and severity of these infections are reduced.
Vitamin E is essential for immune system function and may lower disease risk by enhancing immune responses. It protects neurons and respiratory mucosa from oxidative damage and has been linked to a reduced incidence of asthma and inflammation, potentially safeguarding young children from atopy and wheezing.
There are no available studies in our locality about the effect of vitamin E supplementation on the length of hospital stay for non-cyanotic cardiac patients with lower respiratory tract infections.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | Active comparator | Drug: Vitamin EThe intervention group will receive vitamin E in an appropriate dose during the hospital stay with the treatment protocol for chest infection |
| control group | No intervention | –The control group will receive the treatment protocol for chest infection only or with placebo instead of vitamin E. |
Who may qualify
- Ages
- 2 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Pediatric patients are diagnosed with non-cyanotic heart disease associated with severe lower respiratory tract infection. ⁃ The patients are aged 2 months to 5 years of both sexes.
Key exclusion criteria (4 listed)
- Pediatric patients that have other congenital anomalies other than CHD.
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 |
|---|---|---|
| Vitamin Edose of vitamin E in an appropriate dose for age during hospital stay for intervention group | Drug | intervention |
Primary outcome
the length of hospital stay
Time frame: During the intervention
The effect of vitamin E supplementation on the length of hospital stay in non-cyanotic cardiac pediatric patients with lower respiratory tract infections.
1 secondary outcome
risk factors
Time frame: During the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- Background[1] M. M. Djer and D. B. S. , Emilda Osmardin, Badriul Hegar, "Increased Risk of Recurrent Acute Respiratory Infections in Children with Congenital Heart Disease: A Prospective Cohort Study," Indones. Biomed. J., vol. 12, no. 4, p. p.288-389, 2020, doi: 10.18585/inabj.v12i4.1262. [2] E. Kılıçoğlu and Z. Ü. Tutar, "Evaluation of Children with Congenital Heart Disease Hospitalized with the Diagnosis of Lower Respiratory Tract Infection," J. Pediatr. Res., vol. 5, no. July 2017, pp. 32-36, 2018. [3] Z. Chen, "Circulating micronutrient levels and respiratory infection susceptibility and severity : a bidirectional Mendelian randomization analysis," no. August, 2024, doi: 10.3389/fnut.2024.1373179. [4] A. M. M. Hamed, Y. T. Kassem, H. K. Fayed, and A. M. Solaiman, "Serum zinc levels in hospitalized children with pneumonia: a hospital-based case-control study," Egypt. J. Bronchol., vol. 13, no. 5, pp. 730-737, 2019, doi: 10.4103/ejb.ejb_30_19. [5] N. K. Jat, D. K. Bhagwani, N. Bhutani, U. Sharma, R. Sharma, and R. Gupta, "Assessment of the prevalence of congenital heart disease in children with pneumonia in tertiary care hospital : A cross-sectional study," Ann. Med. Surg., vol. 73, no. November 2021, p. 103111, 2022, doi: 10.1016/j.amsu.2021.103111. [6] O. Investigation, "The Role of the Micronutrients; Vitamin A, Vitamin B12, Iron, Zinc, Copper Levels of Children with Lower Respiratory Tract Infections," pp. 105-109, 2005, doi: 10.5152/ced.2014.1319. [7] M. X. Wang, J. Koh, and J. Pang, "Association between micronutrient deficiency and acute respiratory infections in healthy adults : a systematic review of observational studies," pp. 1-12, 2019. [8] P. C. Calder and P. Yaqoob, "Nutrient Regulation of the Immune Response," Present Knowl. Nutr. Tenth Ed., no. January, pp. 688-708, 2012, doi: 10.1002/9781119946045.ch44. [9] S. Wu and A. Wang, "Serum level and clinical significance of vitamin E in pregnant women with allergic rhinitis," J. Chinese Med. Assoc., vol. 85, no. 5, pp. 597-602, 2022, doi: 10.1097/JCMA.0000000000000723. [10] S. I. Fahmy, L. M. Nofal, S. F. Shehata, H. M. El, and H. K. Ibrahim, "Updating indicators for scaling the socioeconomic level of families for health research," pp. 1-7, 2015, doi: 10.1097/01.EPX.0000461924.05829.93. [11] J. Thokngaen and W. Karoonboonyanan, "Pediatric respiratory severity score evaluates disease severity of respiratory tract infection in children," Chulalongkorn Med. J., vol. 63, no. 1, pp. 41-46, 2019, doi: 10.14456/clmj.1476.6. [12] T. Bohn et al., "Scientific opinion on the tolerable upper intake level for vitamin E," vol. 22, pp. 1-104, 2024, doi: 10.2903/j.efsa.2024.8953.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vitamin E in people with Respiratory Disease, run by Assiut University.
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 4 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: opening soon, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact safaa ahmed, master (01016896337, s.ahmed2795@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the length of hospital stay (time frame: During the intervention). 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 NCT06926712, which also lists 1 linked publication.
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 15 Apr 2025.