Effectiveness of Folic Acid Supplementation in Acute Watery Diarrhea Among Children Under 5 Years of Age
试验速览
- 阶段
- 4 期
- 入组人数
- 324
- 试验地点
- 1
- 主要终点
- Changing the frequency of stools
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 2 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 2months- 5 years
- •Both genders
- •Acute watery diarrhea as per operational definition
- •Diarrhea of less than 7-day duration
排除标准
- •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.
研究组 & 干预措施
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
干预措施: L-Methylfolate Calcium (Drug)
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.
干预措施: L-Methylfolate Calcium (Drug)
结局指标
主要结局
Changing the frequency of stools
时间窗: 5 days
L-methylfolate supplementation is effective in changing the frequency of stools. It will be measured in episodes per day
Effectiveness in changing duration of diarrhea
时间窗: 5 days
L-methylfolate supplementation is effective in changing duration of diarrhea in days.
Effectiveness in improving grades of diarrhea
时间窗: 5 days
L-methylfolate supplementation is effective in changing grades of diarrhea. WHO grades will be taken as reference
次要结局
未报告次要终点
研究者
rafia Jamil
Post Graduate Resident (MD Pediatric Medicine)
King Edward Medical University