Effectiveness of Folic Acid Supplementation in Acute Watery Diarrhea Among Children Under 5 Years of Age
NCT ID: NCT04782037
Last Updated: 2022-05-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
324 participants
INTERVENTIONAL
2020-10-21
2022-07-01
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
SINGLE
Study Groups
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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
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Both genders
* Acute watery diarrhea as per operational definition
* Diarrhea of less than 7-day duration
Exclusion Criteria
* 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.
2 Months
5 Years
ALL
No
Sponsors
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King Edward Medical University
OTHER
Responsible Party
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rafia Jamil
Post Graduate Resident (MD Pediatric Medicine)
Principal Investigators
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MUHAMMAD Haroon HAMID, MBBS,FCPS
Role: PRINCIPAL_INVESTIGATOR
CHAIRMAN PEDIATRIC MEDICINE, MAYO HOSPITAL
Sadia shabir, MBBS, FCPS
Role: PRINCIPAL_INVESTIGATOR
ASSISTANT PROFESSOR, PEDIATRIC MEDICINE UNIT 1, MAYO HOSPITAL
Locations
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Mayo hospital
Lahore, Punjab Province, Pakistan
Countries
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Central Contacts
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Facility Contacts
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Sadia Shabir, MBBS,FCPS
Role: backup
References
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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.
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.
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.
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.
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.
Other Identifiers
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321/RC/KEMU
Identifier Type: -
Identifier Source: org_study_id
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