NCT04782037

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
324

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 21, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 4, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

May 19, 2022

Status Verified

May 1, 2022

Enrollment Period

1.7 years

First QC Date

March 1, 2021

Last Update Submit

May 12, 2022

Conditions

Diarrhoea;Acute

Keywords

acute watery diarrheafolic acidL-methylfolate

Outcome Measures

Primary Outcomes (3)

  • Changing the frequency of stools

    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

    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

    L-methylfolate supplementation is effective in changing duration of diarrhea in days.

    5 days

Study Arms (2)

L-methylfolate supplementation

EXPERIMENTAL

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

distilled water

PLACEBO COMPARATOR

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

Interventions

L-Methylfolate CalciumDRUG

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.

L-methylfolate supplementationdistilled water

Eligibility Criteria

Age2 Months - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo hospital

Lahore, Punjab Province, 56000, Pakistan

RECRUITING

Related Publications (8)

  • Kotloff KL. The Burden and Etiology of Diarrheal Illness in Developing Countries. Pediatr Clin North Am. 2017 Aug;64(4):799-814. doi: 10.1016/j.pcl.2017.03.006.

    PMID: 28734511BACKGROUND

  • GBD Diarrhoeal Diseases Collaborators. Estimates of global, regional, and national morbidity, mortality, and aetiologies of diarrhoeal diseases: a systematic analysis for the Global Burden of Disease Study 2015. Lancet Infect Dis. 2017 Sep;17(9):909-948. doi: 10.1016/S1473-3099(17)30276-1. Epub 2017 Jun 1.

    PMID: 28579426BACKGROUND

  • Walker CLF, Rudan I, Liu L, Nair H, Theodoratou E, Bhutta ZA, O'Brien KL, Campbell H, Black RE. Global burden of childhood pneumonia and diarrhoea. Lancet. 2013 Apr 20;381(9875):1405-1416. doi: 10.1016/S0140-6736(13)60222-6. Epub 2013 Apr 12.

    PMID: 23582727BACKGROUND

  • Ahs JW, Tao W, Löfgren J, Forsberg BC. Diarrheal diseases in low-and middle-income countries: incidence, prevention, and management. Open Infect Dis J. 2010; 4(1):113-24.

    BACKGROUND

  • Crider KS, Yang TP, Berry RJ, Bailey LB. Folate and DNA methylation: a review of molecular mechanisms and the evidence for folate's role. Adv Nutr. 2012 Jan;3(1):21-38. doi: 10.3945/an.111.000992. Epub 2012 Jan 5.

    PMID: 22332098BACKGROUND

  • Kadhum RJ, Alghizzi EJ. The effect of oral folic acid supplementation on the course of acute infantile diarrhea. J Kerbala Univ. 2010; 8(4):177-82.

    BACKGROUND

  • Amelia A, Sinohaji AB, Supriatmo. Folic acid and acute diarrhea in children. Pediatr Indones. 2014; 54(5):273-9

    BACKGROUND

  • 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.

    PMID: 31673504BACKGROUND

Study Officials

  • MUHAMMAD Haroon HAMID, MBBS,FCPS

    CHAIRMAN PEDIATRIC MEDICINE, MAYO HOSPITAL

    PRINCIPAL INVESTIGATOR

  • Sadia shabir, MBBS, FCPS

    ASSISTANT PROFESSOR, PEDIATRIC MEDICINE UNIT 1, MAYO HOSPITAL

    PRINCIPAL INVESTIGATOR

Central Study Contacts

RAFIA M JAMIL, MBBS

CONTACT

0092-330-4513250rafiajamil15@gmail.com

MUHAMMAD HAROON Haroon HAMID, MBBS,FCPS

CONTACT

0092-300-8880916profharoon@kemu.edu.pk

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post Graduate Resident (MD Pediatric Medicine)

Study Record Dates

First Submitted

March 1, 2021

First Posted

March 4, 2021

Study Start

October 21, 2020

Primary Completion

July 1, 2022

Study Completion

July 1, 2022

Last Updated

May 19, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)