Ignite Creation Date:
2024-05-06 @ 3:51 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04782037
Status:
UNKNOWN
Last Update Posted:
2022-05-19
First Post:
2021-03-01
Brief Title:
Effectiveness of Folic Acid Supplementation in Acute Watery Diarrhea Among Children Under 5 Years of Age
Sponsor:
King Edward Medical University
Organization:
King Edward Medical University
Study Overview
Official Title:
Effectiveness of Folic Acid Supplementation in Acute Watery Diarrhea Among Children Under 5 Years of Age
Status:
UNKNOWN
Status Verified Date:
2022-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Folic acid is a palatable and easily available drug with no serious adverse effects L-methylfolate is its biologically activated form and is preferred because of its direct availability for certain metabolic processes As there is no specific and safe drug available that may help in decreasing the duration of diarrhea purging rate or consistency of stools and having known the theoretical benefits of folic acid in this regard it would be appropriate to assess the effectiveness of L-methylfolate among children with diarrhea
Detailed Description:
After approval from the Institutional Review Board of King Edward Medical University Mayo Hospital Lahore all children diagnosed with acute watery diarrhea as per operational definition fulfilling the inclusion criteria presenting to the Department of Pediatrics Mayo Hospital will be enrolled in this study
Informed written consent will be taken from the parentsguardians of all participants A detailed history and examination of each subject would be done by an investigator at presentation
Patients will be randomized in two groups - A and B by lottery method There will be 162 patients in each group The treatment regimen that includes breast feeding nutritional advice rehydration plan ORT by low osmolar ORS or intravenous rehydration if required and zinc sulphate will be given according to the WHO guidelines to all patients of both groups Children under 1 year of age in group A will receive 3 drops 90mcg of L-methylfolate calcium while those older than 1 year of age will be given 5 drops 150mcg Subjects in Group B will receive equal amount of distilled water as placebo ie 3 drops to 1yr age and 5 drops to 1 yr Frequency and grades of loose stools in both groups will be assessed daily and written down on a predesigned proforma
Informed written consent will be taken from the parentsguardians of all participants A detailed history and examination of each subject would be done by an investigator at presentation
Patients will be randomized in two groups - A and B by lottery method There will be 162 patients in each group The treatment regimen that includes breast feeding nutritional advice rehydration plan ORT by low osmolar ORS or intravenous rehydration if required and zinc sulphate will be given according to the WHO guidelines to all patients of both groups Children under 1 year of age in group A will receive 3 drops 90mcg of L-methylfolate calcium while those older than 1 year of age will be given 5 drops 150mcg Subjects in Group B will receive equal amount of distilled water as placebo ie 3 drops to 1yr age and 5 drops to 1 yr Frequency and grades of loose stools in both groups will be assessed daily and written down on a predesigned proforma
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None