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NCT04782037

Effectiveness of Folic Acid Supplementation in Acute Watery Diarrhea Among Children Under 5 Years of Age

Status unknown Phase 4 Last updated 19 May 2022
What this trial tests

Phase 4 trial testing L-Methylfolate Calcium in Diarrhoea;Acute in 324 participants. Status unknown.

Timeline
21 October 2020
Primary endpoint
1 July 2022
1 July 2022

Quick facts

Lead sponsorKing Edward Medical University
PhasePhase 4
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designfactorial
Maskingsingle
Primary purposetreatment
Enrollment324
Start date21 October 2020
Primary completion1 July 2022
Estimated completion1 July 2022
Sites1 location across Pakistan

Drugs / interventions tested

Conditions studied

Sponsor

King Edward Medical University

Who can join

Adults 2 Months to 5, any sex, with Diarrhoea;Acute. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Diarrhoea;Acute

Currently open trials in the same condition.

Other King Edward Medical University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing