The Effect of Vitamin E Supplementation on Hospital Stay Duration in Non-cyanotic Heart Disease Children With Lower Respiratory Tract Infections

NCT06926712 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: safaa1451995protocol
• Study Type: interventional
• Target: 260
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Keywords

RTI-VIT E- CHD

Outcome Measures

Primary Outcomes (1)

• 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.

  During the intervention

Secondary Outcomes (1)

• risk factors

  During the intervention

Study Arms (2)

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

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.

Interventions

Vitamin E DRUG

dose of vitamin E in an appropriate dose for age during hospital stay for intervention group

intervention

Eligibility Criteria

• Age: 2 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (1)

• [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.

  BACKGROUND

MeSH Terms

Conditions

Respiration Disorders

Interventions

Vitamin E

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

safaa ahmed, master

CONTACT

01016896337; s.ahmed2795@gmail.com

safaa ahmed, master

CONTACT

01016896337; safaaAM@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Safaa Ahmed Mohamed Ali, lecturer assesstant at family medicine department

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: April 15, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 15, 2025

Record last verified: 2025-04