Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 3:57 AM
Study NCT ID:
NCT07414693
Status:
RECRUITING
Last Update Posted:
2026-02-17
First Post:
2026-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Vitamin C on Length of Hospital Stay in Children With Severe Pneumonia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011014', 'term': 'Pneumonia'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001205', 'term': 'Ascorbic Acid'}], 'ancestors': [{'id': 'D013400', 'term': 'Sugar Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-02-27', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-12', 'studyFirstSubmitDate': '2026-02-04', 'studyFirstSubmitQcDate': '2026-02-12', 'lastUpdatePostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hospital Stay', 'timeFrame': 'From randomization to hospital discharge, assessed at discharge (up to 30 days).', 'description': 'Duration of Hospital Stay in days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pneumonia', 'Vitamin C', 'Hospital Stay'], 'conditions': ['Pneumonia Childhood', 'Vitamin C', 'Hospital Stay Time']}, 'descriptionModule': {'briefSummary': "Severe pneumonia is a common and serious illness in young children and often requires hospital admission. This clinical trial aims to find out whether adding vitamin C to standard treatment can reduce the length of hospital stay in children under five years of age admitted with severe pneumonia.\n\nThe main question this study seeks to answer is:\n\nDoes giving vitamin C along with routine treatment help children with severe pneumonia recover faster and go home earlier compared to standard treatment alone?\n\nIn this study, 90 children aged 2 to 59 months who are admitted to the Children's Hospital Multan with severe pneumonia will take part. Severe pneumonia is defined by fast breathing, fever, cough, and one or more danger signs such as difficulty feeding, repeated vomiting, seizures, bluish discoloration of lips, or noisy breathing. Children with chronic lung disease or weakened immunity will not be included.\n\nAfter parental consent, children will be randomly divided into two groups. One group will receive standard treatment only, which includes oxygen therapy and intravenous antibiotics according to hospital protocol. The second group will receive the same standard treatment plus a daily dose of vitamin C. Neither group will receive any experimental or unapproved therapy.\n\nResearchers will closely monitor each child's recovery, including improvement in breathing rate, temperature, oxygen levels, and overall clinical condition. The child will be discharged when the treating physician determines that recovery criteria are met. The number of days spent in the hospital from the start of treatment until discharge will be recorded.\n\nBy comparing the average hospital stay between the two groups, this study aims to determine whether vitamin C is a useful and safe add-on treatment for severe pneumonia in young children. The findings may help improve care and reduce hospital stay for children with severe pneumonia in the future."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '59 Months', 'minimumAge': '2 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* presenting with severe pneumonia\n* ≤ 48-hours duration\n\nExclusion Criteria:\n\n* Congenital heart disease\n* Children with chronic respiratory illnesses i.e. Asthma, post tuberculosis bronchiectasis and cystic fibrosis\n* Immunosuppressed i.e. primary immune deficiency, malignancy, on steroid therapy'}, 'identificationModule': {'nctId': 'NCT07414693', 'briefTitle': 'Effect of Vitamin C on Length of Hospital Stay in Children With Severe Pneumonia', 'organization': {'class': 'OTHER_GOV', 'fullName': "Children's Hospital and Institute of Child Health, Multan"}, 'officialTitle': 'Efficacy of Vitamin C as an Adjunct to Standard Treatment in Severe Pneumonia in Children Under Five Years of Age: A Clinical Comparison', 'orgStudyIdInfo': {'id': 'U1111-1334-9511'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard care', 'description': 'Standard care alone', 'interventionNames': ['Drug: Antibiotics administration']}, {'type': 'EXPERIMENTAL', 'label': 'Adjunct Vitamin C', 'description': 'Standard care plus vitamin C', 'interventionNames': ['Drug: Antibiotics administration', 'Drug: Vitamin C']}], 'interventions': [{'name': 'Antibiotics administration', 'type': 'DRUG', 'description': 'Antibiotics Plus supportive care including oxygen inhalation, intravenous rehydration, and antipyretics', 'armGroupLabels': ['Adjunct Vitamin C', 'Standard care']}, {'name': 'Vitamin C', 'type': 'DRUG', 'otherNames': ['Ascorbic acid'], 'description': 'Standard care (oxygen inhalation, intravenous rehydration, and antipyretics) plus Vitamin C: 200-mg (2 cc = 4 dropper, should be mixed in milk or water) once a day', 'armGroupLabels': ['Adjunct Vitamin C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60000', 'city': 'Multan Khurd', 'state': 'Punjab Province', 'status': 'RECRUITING', 'country': 'Pakistan', 'contacts': [{'name': 'Muhammad S Principal Investigator, MBBS', 'role': 'CONTACT', 'email': 'msulaman1432@gmail.com', 'phone': '+92 302 2513701'}, {'name': 'Ayesha F Assistant Professor, FCPS', 'role': 'CONTACT', 'email': 'drayeshafayyaz@yahoo.com', 'phone': '+92 333 6163845'}, {'name': 'Muhammad S Principal Investigator, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Children Hospital and Institute of Child Health', 'geoPoint': {'lat': 33.03555, 'lon': 72.01752}}], 'centralContacts': [{'name': 'Muhammad S Principal Investigator, MBBS', 'role': 'CONTACT', 'email': 'msulaman1432@gmail.com', 'phone': '+92 302 2513701'}, {'name': 'Ayesha F Assistant Professor, FCPS', 'role': 'CONTACT', 'email': 'drayeshafayyaz@yahoo.com', 'phone': '+92 333 6163845'}], 'overallOfficials': [{'name': 'Ayesha F Assitant Professor, FCPS', 'role': 'STUDY_CHAIR', 'affiliation': 'Children Hospital and Institute of Child Health, Multan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital and Institute of Child Health, Multan", 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Muhammad Sulaman', 'investigatorAffiliation': "Children's Hospital and Institute of Child Health, Multan"}}}}