Zinc Supplementation to Reduce Diarrhea Rates in Adults in Western Kenya.

Summary

Zinc deficiency is prevalent in children in developing countries. Zinc-supplementation is proven to reduce the duration and severity of childhood diarrhea in randomized controlled trials. However, despite this evidence, its efficacy to reduce diarrhea morbidity in adults remains unknown. The main objective of this study is to determine the efficacy of Zn-supplementation on diarrhea incidences in a vulnerable adult population. The study will be carried out in Kombewa division, Kisumu District and will involve 500 adults aged 18-55 years. They will be randomly assigned to receive Zn supplement (or placebo) on a daily basis over a 3 month period. Morbidity information will be collected daily for 4 months, while anthropometric measures and laboratory data will be obtained at study onset, end of supplementation and study conclusion. In addition, HIV and malaria tests will be carried out during the study as they are important confounders. The significant differences in diarrhea incidence between the Zn-group and the placebo-group will be determined using SPSS. The results are expected to provide the scientific basis and common pathway for development of an anti-diarrheal supplement for vulnerable populations such as environmental refugees, deprived and displaced persons, and troops prior to deployment.

Conditions

• Diarrhea
• Malaria

Interventions

DIETARY_SUPPLEMENT

Zinc sulphate

Volunteers will be randomly assigned to either receive zinc sulphate supplements (20 mg/capsule) or a placebo containing no zinc. Maltodextrin serves as the carrier. The manufacturer is Tishcon Corporation, Westbury, NY.

OTHER

Placebo

Volunteers will be randomly assigned to either receive zinc sulphate supplements (20 mg/capsule) or a placebo containing no zinc. Maltodextrin serves as the carrier. The manufacturer is Tishcon Corporation, Westbury, NY.

Sponsors & Collaborators

• Walter Reed Army Institute of Research (WRAIR)

  collaborator FED

• United States Army Research Institute of Environmental Medicine

  lead FED

Principal Investigators

• Maria E Bovill, Dr.PH · U.S. Army Medical Research Unit - Kenya (USAMRU-K), Kisumu, Kenya

• Mark E Polhemus, MD · U.S. Army Medical Research Unit - Kenya (USAMRU-K), Kisumu, Kenya

• Lucas Otieno, MB.ChB · Kenya Medical Research Institute (KEMRI)/Walter Reed Project (WRP), Kisumu, Kenya

• Stella K Apollo, BSN · Walter Reed Project (WRP), Kisumu, Kenya

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2007-07-31

Primary Completion

2008-01-31

Completion

2008-01-31

Countries

• United States
• Kenya

Study Locations