Zinc-ORS in Severe and Complicated Acute Diarrhea
Summary
Three-hundred-and-fifty-two males aged 1-36 months with acute non-dysenteric diarrhoea and no systemic illness will be enrolled in this clinical trial. Eligible children will be stratified by their age (1up to 5 months, 6-35 months). Within the two age strata the patients will be randomized to receive zinc-ORS (fortified with 40 mg elemental zinc as zinc gluconate per litre) or standard WHO ORS. The major outcome measures will be stool output and duration of diarrhea. The safety of administering zinc will be determined by examining the effect of zinc ingestion on vomiting, sodium and potassium homeostasis, plasma zinc and copper, and iron stores and concentration of serum transferrin receptor.
Timeline
- Start
- 2003-09
- Primary completion
- —
- Completion
- 2006-12
Outcome
Missed primary endpoint
paper ORS containing zinc does not reduce duration or stool volume of acute diarrhea in hospitalized children. PMID 21788757 ↗
paper The time to recovery was also similar in the 2 groups (hazard ratio 1.06 [95% confidence interval 0.88-1.27]). PMID 21788757 ↗
Publications
- Background Strand TA, Chandyo RK, Bahl R, Sharma PR, Adhikari RK, Bhandari N, Ulvik RJ, Molbak K, Bhan MK, Sommerfelt H. Effectiveness and efficacy of zinc for the treatment of acute diarrhea in young children. Pediatrics. 2002 May;109(5):898-903. doi: 10.1542/peds.109.5.898.
- Background Mahalanabis D, Chowdhury A, Jana S, Bhattacharya MK, Chakrabarti MK, Wahed MA, Khaled MA. Zinc supplementation as adjunct therapy in children with measles accompanied by pneumonia: a double-blind, randomized controlled trial. Am J Clin Nutr. 2002 Sep;76(3):604-7. doi: 10.1093/ajcn/76.3.604.
- Background Mahalanabis D, Bhan MK. Micronutrients as adjunct therapy of acute illness in children: impact on the episode outcome and policy implications of current findings. Br J Nutr. 2001 May;85 Suppl 2:S151-8. doi: 10.1079/bjn2000308.
- Background Fontaine O. Effect of zinc supplementation on clinical course of acute diarrhoea. J Health Popul Nutr. 2001 Dec;19(4):339-46.
- Background Brooks WA, Santosham M, Roy SK, Faruque AS, Wahed MA, Nahar K, Khan AI, Khan AF, Fuchs GJ, Black RE. Efficacy of zinc in young infants with acute watery diarrhea. Am J Clin Nutr. 2005 Sep;82(3):605-10. doi: 10.1093/ajcn.82.3.605.
- Background Bahl R, Bhandari N, Saksena M, Strand T, Kumar GT, Bhan MK, Sommerfelt H. Efficacy of zinc-fortified oral rehydration solution in 6- to 35-month-old children with acute diarrhea. J Pediatr. 2002 Nov;141(5):677-82. doi: 10.1067/mpd.2002.128543.
- Background Baqui AH, Black RE, El Arifeen S, Yunus M, Chakraborty J, Ahmed S, Vaughan JP. Effect of zinc supplementation started during diarrhoea on morbidity and mortality in Bangladeshi children: community randomised trial. BMJ. 2002 Nov 9;325(7372):1059. doi: 10.1136/bmj.325.7372.1059.
- Background Bhandari N, Bahl R, Taneja S, Strand T, Molbak K, Ulvik RJ, Sommerfelt H, Bhan MK. Substantial reduction in severe diarrheal morbidity by daily zinc supplementation in young north Indian children. Pediatrics. 2002 Jun;109(6):e86. doi: 10.1542/peds.109.6.e86.
- Background Sazawal S, Black RE, Bhan MK, Bhandari N, Sinha A, Jalla S. Zinc supplementation in young children with acute diarrhea in India. N Engl J Med. 1995 Sep 28;333(13):839-44. doi: 10.1056/NEJM199509283331304.
- Wadhwa N, Natchu UC, Sommerfelt H, Strand TA, Kapoor V, Saini S, Kainth US, Bhatnagar S. ORS containing zinc does not reduce duration or stool volume of acute diarrhea in hospitalized children. J Pediatr Gastroenterol Nutr. 2011 Aug;53(2):161-7. doi: 10.1097/MPG.0b013e318213ca55.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Zinc Sulfate | Unknown | 0.04 mg/ml | Oral |