Zinc-ORS in Severe and Complicated Acute Diarrhea
Condition: Diarrhea; Dehydration
MeSH terms: Dehydration; Diarrhea
Study type: Interventional
Phase: Phase 2/Phase 3

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.
    

Detailed description: 
      Zinc deficiency is prevalent in developing countries due to inadequate food intake, low
      intake of foods from animal sources and high dietary intake of phytate, a substance that
      reduces zinc absorption. A recently completed trial at All India Institute Of Medical
      Sciences (AIIMS) measured the effect of zinc-ORS in the community, where most episodes are
      relatively mild. Zinc-ORS was efficacious in reducing the total number of stools (19%
      relative risk reduction, 95% CI 15% to 23%) and duration of diarrhoea (11% relative risk
      reduction, 95% CI 4% to 24%). In order to make policy decisions that standard ORS provided to
      children be fortified with zinc the national (and international) child health programs need a
      similar evidence base also for children hospitalized because of acute diarrhea. This is
      because these children represent the more severe end of the disease spectrum, i.e. they are
      the ones who are at the highest risk of dying.

      The primary objective is to conduct a study of zinc-ORS in a hospital setting (i.e. of more
      severe diarrhea) to optimize and accurately measure the amount of zinc-ORS consumed and
      monitor stool output which is not possible in a field setting. The study will also examine
      the safety of using zinc-ORS; whether zinc-ORS affects the blood levels of sodium and
      potassium and of other micronutrients than zinc, such as copper and iron. The study will
      contribute to introducing a more efficacious ORS and help increase the ORS use rate which
      continues to be an important public health challenge in India.

      The study will be carried out at two Clinical Research Facilities supervised by the Centre
      for Diarrhoeal Diseases and Nutrition Research, Division of Gastroenterology, Department of
      Pediatrics, AIIMS. 352 males aged 1-36 months with acute non-dysenteric diarrhoea and no
      systemic illness will be enrolled. Eligible children will be first 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. Minimum period of the study will be 48 hours and
      subjects will be discharged when diarrhoea has ceased or at 48 hours, whichever is later.
    

Intervention name(s): Zinc sulphate
Intervention type(s): Drug
Intervention MeSH terms: Zinc Sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Children; India; Hospital; Zinc; Malnutrition; Treatment