Impact of Home Zinc Treatment for Acute Diarrhea in Children

NCT00530829 | Completed Phase 3

• 1 other identifier: CDC-NCPDCID-4678
• Study Type: interventional
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

Background. Zinc deficiency is common in Africa. It has been shown in Asia that zinc as treatment for diarrhea can shorten the course of episodes of diarrhea, as well as prevent future episodes. The use of zinc at home to treat diarrhea in an African setting, where malaria, HIV and malnutrition are common, has not been well-studied. Objective. To evaluate if zinc treatment for diarrhea given at home in Kenyan children will decrease the community prevalence of diarrhea more than zinc given only in the clinic Work planned. We propose to do a community-randomized intervention study of 10 days of dispersible zinc tablets given in the home, in addition to ORS, to treat diarrhea in children under-5 years of age living in a rural part of Bondo District. The comparison group will be children who receive zinc and ORS in the clinic only. The primary outcome will be a comparison of the prevalence of diarrhea in home zinc versus nonhome zinc villages. Secondary outcomes will be the incidence of repeat episodes of diarrhea, the duration of diarrheal illness, the prevalence of acute respiratory infection, and the effect of malaria infection on treatment with zinc. Thirty-three villages (approximately 1300 children) will be enrolled and children will be followed for 1 year. Significance of results. If this study shows zinc given at home to be effective, this might be considered by the Kenyan MOH as an essential component of the treatment of diarrhea in children at the community level.

Conditions

Diarrhea

Keywords

diarrhea; zinc; oral rehydration therapy

Outcome Measures

Primary Outcomes (1)

• To assess if access to zinc treatment for diarrhea in the home in addition to zinc treatment of diarrhea in the clinic leads to a greater reduction in the prevalence of diarrhea than giving zinc for treatment of diarrhea in the clinic only

  One year

Secondary Outcomes (1)

• To assess if access to zinc treatment for diarrhea in the home in addition to zinc treatment of diarrhea in the clinic decreases the likelihood of recurrent diarrhea episodes, acute respiratory infections, and antimicrobial use

  one year

Study Arms (2)

1

EXPERIMENTAL

Mothers recieve a blister pack of zinc tablets in home every two months for use when child in home under 5 years has diarrhea. ORS satchets also given. Instructions on when and how to use zinc and ORS and when to take child in clinic are given by community health worker. Zinc will also be given in clinic if child visits clinic with diarrhea and has not yet started zinc at home.

Drug: zinc

2

ACTIVE COMPARATOR

Mothers recieve ORS satchets at home every two months for use when child in home under 5 years has diarrhea. Instructions on when and how to use ORS and when to take child in clinic are given by community health worker. Zinc will be given in clinic if child visits clinic with diarrhea.

Drug: zinc

Interventions

zinc DRUG

10 day blister pack of 20 mg zinc disperable tablets, 1 tablet qd for children 6 months to 4 years, 1/2 tablet qd for children 2-5 months

1; 2

Eligibility Criteria

• Age: 2 Months - 4 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• All children 2 to 59 months of age in households within 33 selected villages

You may not qualify if:

• Children under 2 months of age will not be eligible for enrollment, until they reach 2 months of age as the role of zinc has not been well-studied in neonates. Children of parents who do not give written informed consent for their participation will not be enrolled.

Sponsors & Collaborators

• Centers for Disease Control and Prevention: lead
• Kenya Medical Research Institute: collaborator
• International Centre for Diarrhoeal Disease Research, Bangladesh: collaborator

Study Sites (1)

Kenya Medical Research Institute

Kisumu, Kenya

Location

Related Publications (1)

• Feikin DR, Bigogo G, Audi A, Pals SL, Aol G, Mbakaya C, Williamson J, Breiman RF, Larson CP. Village-randomized clinical trial of home distribution of zinc for treatment of childhood diarrhea in rural Western kenya. PLoS One. 2014 May 16;9(5):e94436. doi: 10.1371/journal.pone.0094436. eCollection 2014.

  PMID: 24835009 DERIVED

Related Links

• Document WHO/FCH/CAH/04.7

MeSH Terms

Conditions

Diarrhea

Interventions

Zinc

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• Daniel R Feikin, MD

  Centers for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED

Study Record Dates

• First Submitted: September 17, 2007
• First Posted: September 18, 2007
• Study Start: October 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: March 9, 2010

Record last verified: 2010-03

Locations

KE (1)