Oral Zinc for the Treatment of Acute Diarrhea in US Children
| Status: | Completed |
|---|---|
| Conditions: | Irritable Bowel Syndrome (IBS), Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | Any - 6 |
| Updated: | 8/24/2018 |
| Start Date: | November 2010 |
| End Date: | June 2015 |
A Double Blind Randomized Placebo Controlled Trial of Oral Zinc for Children With Acute Diarrhea in a Developed Nation.
Diarrheal diseases are the third leading cause of mortality in the world, with nearly 2
million deaths annually among children under age 5 years. Several clinical trials of oral
zinc supplementation performed in developing country populations have confirmed this
nutrient's efficacy in reducing the severity and frequency of diarrhea. The World Health
Organization (WHO) has recommended global use of zinc supplementation in all children with
diarrhea despite little or no data from trials in industrialized/developed settings. In the
United States over 4 million children suffer annually from diarrheal illness. Although
mortality is not a significant factor in U.S. cases, 75% of all cases present to medical care
resulting in over 200,000 hospitalizations annually for diarrhea. This has significant impact
on U.S. healthcare costs, with an average of $391 per outpatient treatment and $2,549 per
inpatient treatment spent on each episode of acute diarrheal illness. The goal of this study
is to evaluate the effectiveness of oral zinc in decreasing the duration of diarrhea in
children treated as outpatients and in decreasing the duration of hospitalization in children
treated as inpatients in an industrialized country. The results of this study promise to have
a substantial impact on the management of a common pediatric health problem, and could
conceivably affect direct and indirect healthcare costs to society.
million deaths annually among children under age 5 years. Several clinical trials of oral
zinc supplementation performed in developing country populations have confirmed this
nutrient's efficacy in reducing the severity and frequency of diarrhea. The World Health
Organization (WHO) has recommended global use of zinc supplementation in all children with
diarrhea despite little or no data from trials in industrialized/developed settings. In the
United States over 4 million children suffer annually from diarrheal illness. Although
mortality is not a significant factor in U.S. cases, 75% of all cases present to medical care
resulting in over 200,000 hospitalizations annually for diarrhea. This has significant impact
on U.S. healthcare costs, with an average of $391 per outpatient treatment and $2,549 per
inpatient treatment spent on each episode of acute diarrheal illness. The goal of this study
is to evaluate the effectiveness of oral zinc in decreasing the duration of diarrhea in
children treated as outpatients and in decreasing the duration of hospitalization in children
treated as inpatients in an industrialized country. The results of this study promise to have
a substantial impact on the management of a common pediatric health problem, and could
conceivably affect direct and indirect healthcare costs to society.
In developing countries, diarrheal diseases are a leading cause of childhood morbidity and
mortality. In the United States an estimated 4.67 million children per year suffer from
gastroenteritis with a diarrheal component, impacting the delivery and cost of healthcare.
Seventy-five percent of these children are brought to physician care across a range of
settings from clinics to emergency departments. Children less than five years of age average
1.3 - 2.5 episodes per year, with 1.4% of those children requiring hospitalization annually.
This results in an estimated 209,000 hospitalizations yearly for gastroenteritis. The impact
of acute gastrointestinal disease can be felt in the developed world, including the United
States, as cost attributed to hospitalization and productivity lost. Attempts at treating
gastroenteritis have included Oral Rehydration Solution (ORS), introduced 30 years ago by the
WHO, which continues to provide a safe and effective way to maintain hydration during acute
illness. ORS, however, does not reduce the volume or frequency of stool output in diarrhea.
The anti-diarrheal medication loperamide (Imodium®) was commonly used in children until
reports of serious adverse reactions caused its use to fall out of favor. There are no other
medications or supplements available to specifically treat the diarrheal component of
gastroenteritis and studies have shown that adherence to treatment recommendations regarding
fluid therapy is poor because care givers want to reduce duration of illness as opposed to
supporting children through the natural course of the disease. The desire to relieve
diarrheal symptoms often leads care givers to seek antibiotics during a time of rising
antibiotic resistance, as well as other treatments with no proven efficacy.
Zinc is an essential trace element for humans. Its physiologic roles are seen throughout the
body as a critical cofactor for enzymatic reactions; most notable are its actions in the
gastrointestinal (GI) tract. Zinc is an important component of brush border enzymatic
activity which promotes gastrointestinal absorption, it regulates water/electrolyte transport
at the cellular level, and it enhances the repair of the intestinal mucosa by bolstering
immune function. Over the past 10-15 years, there have been more than a dozen randomized
controlled trials of zinc supplementation performed in children living in developing
countries that have reported improvements in the duration and severity of diarrhea when
compared to placebo in a variety of in- and outpatient settings. The majority of zinc trials
were conducted in countries at high risk of zinc deficiency, but those conducted at medium
risk showed similar effect on duration and severity. When stratified across all nutritional
groups based on serum zinc levels a significant effect was seen compared to placebo despite
baseline zinc level, with no occurrence of serious adverse reaction in any group. Given these
results, the WHO has endorsed zinc supplementation for all children with acute diarrhea,
despite the lack of data from similarly designed studies in industrialized/developed
settings.
mortality. In the United States an estimated 4.67 million children per year suffer from
gastroenteritis with a diarrheal component, impacting the delivery and cost of healthcare.
Seventy-five percent of these children are brought to physician care across a range of
settings from clinics to emergency departments. Children less than five years of age average
1.3 - 2.5 episodes per year, with 1.4% of those children requiring hospitalization annually.
This results in an estimated 209,000 hospitalizations yearly for gastroenteritis. The impact
of acute gastrointestinal disease can be felt in the developed world, including the United
States, as cost attributed to hospitalization and productivity lost. Attempts at treating
gastroenteritis have included Oral Rehydration Solution (ORS), introduced 30 years ago by the
WHO, which continues to provide a safe and effective way to maintain hydration during acute
illness. ORS, however, does not reduce the volume or frequency of stool output in diarrhea.
The anti-diarrheal medication loperamide (Imodium®) was commonly used in children until
reports of serious adverse reactions caused its use to fall out of favor. There are no other
medications or supplements available to specifically treat the diarrheal component of
gastroenteritis and studies have shown that adherence to treatment recommendations regarding
fluid therapy is poor because care givers want to reduce duration of illness as opposed to
supporting children through the natural course of the disease. The desire to relieve
diarrheal symptoms often leads care givers to seek antibiotics during a time of rising
antibiotic resistance, as well as other treatments with no proven efficacy.
Zinc is an essential trace element for humans. Its physiologic roles are seen throughout the
body as a critical cofactor for enzymatic reactions; most notable are its actions in the
gastrointestinal (GI) tract. Zinc is an important component of brush border enzymatic
activity which promotes gastrointestinal absorption, it regulates water/electrolyte transport
at the cellular level, and it enhances the repair of the intestinal mucosa by bolstering
immune function. Over the past 10-15 years, there have been more than a dozen randomized
controlled trials of zinc supplementation performed in children living in developing
countries that have reported improvements in the duration and severity of diarrhea when
compared to placebo in a variety of in- and outpatient settings. The majority of zinc trials
were conducted in countries at high risk of zinc deficiency, but those conducted at medium
risk showed similar effect on duration and severity. When stratified across all nutritional
groups based on serum zinc levels a significant effect was seen compared to placebo despite
baseline zinc level, with no occurrence of serious adverse reaction in any group. Given these
results, the WHO has endorsed zinc supplementation for all children with acute diarrhea,
despite the lack of data from similarly designed studies in industrialized/developed
settings.
Inclusion Criteria:
- Healthy Children with non-bloody diarrhea illness defined as loose or watery stools
- Symptoms must be present for greater than 24 hours but less than 72 hours.
- Comorbid conditions including; Asthma, Gastroesophageal reflux (unless followed by a
Gastroenterologist), Mild speech, language, motor delays, Benign heart murmurs,
Isolated atrial septal defect (ASD) or ventricular septal defect (VSD), Epilepsy
(unless developmentally delayed), Children born Prematurely between 33-37 weeks
without long term sequelae, Repaired tetralogy of fallot (no cardiac issues for >6
months), Diabetes may be enrolled in the study.
Exclusion Criteria:
- Children with symptoms less than 24 hours
- Children with symptoms greater than 24 hours
- Failure to thrive
- G or J tube
- Major surgery within last 3 months
- Minor surgery (tonsillectomy, ear tubes, skin lesion removals etc) within last 1 month
- Followed by GI service for any reason (crohns, ulcerative colitis, constipation)
- Developmental delay, patient >1 year behind milestones
- Current brain tumor
- Currently being treated for cancer or in remission < 6 months
- Intussuception
- Antibiotics in the last 14 days or currently taking antibiotics for any reason
- Autism
- Children born premature <33 weeks
- Cystic Fibrosis
- Major congenital Heart Disease (any disease where child's baseline oxygen saturations
<93%)
- Short Gut
- Liver disease
- History of bowel resection
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