Clinical trial NCT04782037: Effectiveness of Folic Acid Supplementation in Acute Watery Diarrhea Among Children Under 5 Years of Age
Official title: Effectiveness of Folic Acid Supplementation in Acute Watery Diarrhea Among Children Under 5 Years of Age
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Diarrhoea;Acute
Keywords: acute watery diarrhea
folic acid
L-methylfolate
Lead sponsor: King Edward Medical University
Sponsor class: OTHER
First posted: 2021-03-04
Enrollment: 324
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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 parents/guardians 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 (i.e. 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.

Eligibility criteria: Inclusion Criteria:

* Children aged 2months- 5 years
* Both genders
* Acute watery diarrhea as per operational definition
* Diarrhea of less than 7-day duration

Exclusion Criteria:

* Severely malnourished children \<3 SD
* Bloody diarrhea
* Prolonged (7-14 days duration), persistent (\>14 days duration) or chronic diarrhea (\>4weeks duration)
* Those who received folic acid within the last 14 days
* Hospital-acquired diarrhea (diarrhea occurring after 48hrs of stay in hospital)
* Antibiotic-associated diarrhea.
* Presence of other co morbid conditions like pneumonia, sepsis, meningitis, etc.

Primary outcomes:
measure: Changing the frequency of stools
timeFrame: 5 days
measure: Effectiveness in improving grades of diarrhea
timeFrame: 5 days
measure: Effectiveness in changing duration of diarrhea
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Mayo hospital
state: Punjab
Study officials:
affiliation: CHAIRMAN PEDIATRIC MEDICINE, MAYO HOSPITAL
name: MUHAMMAD Haroon HAMID, MBBS,FCPS
role: PRINCIPAL_INVESTIGATOR
affiliation: ASSISTANT PROFESSOR, PEDIATRIC MEDICINE UNIT 1, MAYO HOSPITAL
name: Sadia shabir, MBBS, FCPS
role: PRINCIPAL_INVESTIGATOR
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citation: Niederberger KE, Dahms I, Broschard TH, Boehni R, Moser R. Safety evaluation of calcium L-methylfolate. Toxicol Rep. 2019 Sep 26;6:1018-1030. doi: 10.1016/j.toxrep.2019.09.012. eCollection 2019.