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

King Edward Medical University

Status and phase: Unknown; Phase 4

Conditions: Diarrhoea;Acute

Treatments: Drug: L-Methylfolate Calcium

Study type: Interventional

Funder types: Other

Identifiers

NCT04782037

321/RC/KEMU

Details and patient eligibility

About

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.

Full 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.

Enrollment: 324 estimated patients

Sex: All

Ages: 2 months to 5 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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324 participants in 2 patient groups, including a placebo group

L-methylfolate supplementation

Experimental group

Description:

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) daily fior 5 days

Treatment:

Drug: L-Methylfolate Calcium

distilled water

Placebo Comparator group

Description:

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.

Treatment:

Drug: L-Methylfolate Calcium