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Diarrhoea;AcutePhase 4NCT04782037

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

A Phase 4 study testing L-Methylfolate Calcium in people with Diarrhoea;Acute, run by King Edward Medical University at 1 site in Pakistan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 2 months to 5 years
Conditions the study is for
Diarrhoea;Acute
What is being tested?
L-Methylfolate Calcium
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
324 participants
Where
1 sitePakistan
Study dates
21 Oct 2020to 1 Jul 2022
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 months to 5 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

RAFIA M JAMIL, MBBS contact

0092-330-4513250

rafiajamil15@gmail.com

MUHAMMAD HAROON Haroon HAMID, MBBS,FCPS contact

0092-300-8880916

profharoon@kemu.edu.pk

Pakistan1 site, 1 recruiting

  • Mayo hospital

    Lahore, Punjab Province, 56000

    Rafia Jamil hospital, MBBS, 0092-330-4513250, rafiajamil15@gmail.com

    Sadia Shabir, MBBS,FCPS, 0092-345-4736393

    Recruiting

Other trials in Pakistan

About this study

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.

Read the 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.

Conditions
Diarrhoea;Acute
Being tested
L-Methylfolate Calcium
Keywords
acute watery diarrhea, folic acid, L-methylfolate

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT04782037
Study groupRoleWhat they receive
L-methylfolate supplementationExperimentalChildren 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
Receives: Drug: L-Methylfolate Calcium
distilled waterPlacebo comparatorSubjects 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.
Receives: Drug: L-Methylfolate Calcium

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changing the frequency of stools

    L-methylfolate supplementation is effective in changing the frequency of stools. It will be measured in episodes per day

    Measured: 5 days

  2. Effectiveness in improving grades of diarrhea

    L-methylfolate supplementation is effective in changing grades of diarrhea. WHO grades will be taken as reference

    Measured: 5 days

  3. Effectiveness in changing duration of diarrhea

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

    Measured: 5 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2021
  2. Study start21 Oct 2020
  3. Primary completion1 Jul 2022 (estimated)
  4. Study completion1 Jul 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Single blind
Who is masked
Participant
Enrolment
324 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04782037
Sponsor's protocol ID
321/RC/KEMU
Status last verified
May 2022
First submitted
1 Mar 2021
Last updated
19 May 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28734511

  • 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.

    PubMed 28579426

  • 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.

    PubMed 23582727

  • 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.

  • 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.

    PubMed 22332098

  • 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.

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

  • 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.

    PubMed 31673504

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing L-Methylfolate Calcium in people with Diarrhoea;Acute, run by King Edward Medical University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact RAFIA M JAMIL, MBBS (0092-330-4513250, rafiajamil15@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changing the frequency of stools (time frame: 5 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04782037, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2022.

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