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

May 12, 2022 updated by: rafia Jamil, King Edward Medical University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

324

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 56000
        • Recruiting
        • Mayo Hospital
        • Contact:
        • Contact:
          • Sadia Shabir, MBBS,FCPS
          • Phone Number: 0092-345-4736393

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 months to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: L-methylfolate supplementation
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
Drug: L-Methylfolate Calcium
Folic acid is one of the water-soluble B vitamins, which is synthetically-produced and found in fortified foods and supplements. It is essential for the synthesis and repair of DNA and RNA and metabolism of amino acids which are required for cell division. There is damage to the intestinal mucosa in most diarrhea cases; therefore, the role of folic acid has been studied as adjuvant therapy for diarrhea since folic acid plays an important role in the synthesis of DNA especially in rapidly regenerating cells.
Placebo Comparator: distilled water
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.
Drug: L-Methylfolate Calcium
Folic acid is one of the water-soluble B vitamins, which is synthetically-produced and found in fortified foods and supplements. It is essential for the synthesis and repair of DNA and RNA and metabolism of amino acids which are required for cell division. There is damage to the intestinal mucosa in most diarrhea cases; therefore, the role of folic acid has been studied as adjuvant therapy for diarrhea since folic acid plays an important role in the synthesis of DNA especially in rapidly regenerating cells.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changing the frequency of stools
Time Frame: 5 days
L-methylfolate supplementation is effective in changing the frequency of stools. It will be measured in episodes per day
5 days
Effectiveness in improving grades of diarrhea
Time Frame: 5 days
L-methylfolate supplementation is effective in changing grades of diarrhea. WHO grades will be taken as reference
5 days
Effectiveness in changing duration of diarrhea
Time Frame: 5 days
L-methylfolate supplementation is effective in changing duration of diarrhea in days.
5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Edward Medical University

Investigators

  • Principal Investigator: MUHAMMAD Haroon HAMID, MBBS,FCPS, CHAIRMAN PEDIATRIC MEDICINE, MAYO HOSPITAL
  • Principal Investigator: Sadia shabir, MBBS, FCPS, ASSISTANT PROFESSOR, PEDIATRIC MEDICINE UNIT 1, MAYO HOSPITAL

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 21, 2020

Primary Completion (Anticipated)

July 1, 2022

Study Completion (Anticipated)

July 1, 2022

Study Registration Dates

First Submitted

March 1, 2021

First Submitted That Met QC Criteria

March 1, 2021

First Posted (Actual)

March 4, 2021

Study Record Updates

Last Update Posted (Actual)

May 19, 2022

Last Update Submitted That Met QC Criteria

May 12, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 321/RC/KEMU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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