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

This study has been completed.
Sponsor:
Collaborator:
Walter Reed Army Institute of Research (WRAIR)
Information provided by:
United States Army Research Institute of Environmental Medicine
ClinicalTrials.gov Identifier:
NCT01166815
First received: July 19, 2010
Last updated: July 21, 2010
Last verified: July 2010
  Purpose

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.


Condition Intervention Phase
Diarrhea
Malaria
Dietary Supplement: Zinc sulphate
Other: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: A Randomized, Double Blind, Controlled Study to Determine the Efficacy of Zinc Supplementation on Diarrhea Incidence in an Adult Population in Western Kenya.

Resource links provided by NLM:


Further study details as provided by United States Army Research Institute of Environmental Medicine:

Primary Outcome Measures:
  • Determine the incidence of diarrhea in zinc vs. placebo-supplemented adults [ Time Frame: Daily, for 104 days ] [ Designated as safety issue: No ]
    Diarrhea is defined as 3 or more loose motions within a period of 24 hours. Field workers will visit each subject to record diarrhea morbidity data, daily for 104 days.


Secondary Outcome Measures:
  • Determine the time to diarrhea onset in both groups [ Time Frame: Daily, for 104 days ] [ Designated as safety issue: No ]
    Daily, field workers will visit each subject to dispense supplement and to record diarrhea morbidity data. The time between day 0 and the first bout of diarrhea will be noted.

  • Determine the duration of each diarrhea episode in both groups [ Time Frame: Daily, for 104 days ] [ Designated as safety issue: No ]
    Daily, field workers will visit each subject to dispense supplement and to record diarrhea morbidity data. With diarrhea defined as >2 loose motions within a period of 24 hours, the duration (number of days) of the diarrhea will be recorded.

  • Determine the number of loose stools/day/episode of diarrhea in both groups [ Time Frame: Daily, for 104 days ] [ Designated as safety issue: No ]
    Daily, field workers will visit each subject to record diarrhea morbidity data. With each bout of diarrhea, we will record the nuber of loose stools/day.


Enrollment: 500
Study Start Date: July 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Zinc supplemented
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. Bulk boxes will identify the products as "A" and "B".
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.
Placebo Comparator: 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. Bulk boxes will identify the products as "A" and "B".
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female between 18 and 55 years of age
  • Written informed consent obtained from the volunteer in Dholuo, Kiswahili or English.
  • Available to participate for the study duration (approximately five months)
  • Negative pregnancy test at screening and study start
  • Not taking any vitamin/mineral supplements for the last 2 months prior to onset of the study.

Exclusion Criteria:

  • Profound clinical evidence of current immunosuppression or evidence of active AIDS defining illness
  • A family history of congenital or hereditary immunodeficiency
  • History of allergic reactions to zinc
  • History of any neurologic disorders or seizures
  • Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, renal functional abnormality, as determined by physical examination or laboratory screening tests
  • ALT above normal range: >60 U/L Male; >40 U/L Female
  • Creatinine above normal range: >1.5 mg/dL
  • Hemoglobin below normal range: <11.0 g/dL Male; <9.5 g/dL Female
  • Total White Cell Count below normal range <3.0 x 103/uL Male; <2.5 x 103/uL Female
  • Absolute lymphocyte count < 1.0 x 103/uL
  • Platelet count below normal range <100 x 103/uL
  • Pregnant female (positive pregnancy test) at time of screening or study start
  • History of chronic alcohol consumption and/or drug abuse
  • Use of any investigational or non-registered drugs or vaccines within 30 days preceding the first dose of the study, or planned use during the study period
  • Any chronic drug therapy to be continued during the study period
  • Simultaneous participation in any other clinical trial
  • Planning to start or unable to discontinue vitamin/mineral supplements other than those supplied by the study
  • HIV positive with current Aids defining illness or CD4 count less than 250 cells/mm3
  • Any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trial
  • Persons having diarrhea at the time of enrollment.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01166815

Locations
United States, Massachusetts
U.S. Army Research Institute of Environmental Medicine (USARIEM)
Natick, Massachusetts, United States, 01760
United States, North Dakota
U.S. Department of Agriculture, Agricultural Research Service, Grand Forks Human Nutrition Center
Grand Forks, North Dakota, United States, 56721
Kenya
Kombewa Clinical Research Center
Kombewa, Kisumu West, Kenya
Sponsors and Collaborators
United States Army Research Institute of Environmental Medicine
Walter Reed Army Institute of Research (WRAIR)
Investigators
Principal Investigator: Maria E Bovill, Dr.PH U.S. Army Medical Research Unit - Kenya (USAMRU-K), Kisumu, Kenya
Principal Investigator: Mark E Polhemus, MD U.S. Army Medical Research Unit - Kenya (USAMRU-K), Kisumu, Kenya
Principal Investigator: Lucas Otieno, MB.ChB Kenya Medical Research Institute (KEMRI)/Walter Reed Project (WRP), Kisumu, Kenya
Study Director: Stella K Apollo, BSN Walter Reed Project (WRP), Kisumu, Kenya
  More Information

Publications:
AG Scrimgeour, HC Lukaski, ME Polhemus, L Otieno, SM McGraw, AJ Young, ME Bovill. Effect of Zinc Supplementation on Diarrhea and Malaria Morbidity in Adults in Rural Kenya. FASEB J. 2010 24:538.12
AG Scrimgeour, HC Lukaski, ME Polhemus, L Otieno, AJ Young, ME Bovill. Zinc supplementation does not alter plasma trace elements in Kenyan adults FASEB J. 2009 23:922.2.

Responsible Party: LTC Maria Bovill, US Army Medical Research Unit - Kenya
ClinicalTrials.gov Identifier: NCT01166815     History of Changes
Other Study ID Numbers: USARIEM C07-04, WRAIR 1332, KEMRI 1332
Study First Received: July 19, 2010
Last Updated: July 21, 2010
Health Authority: United States: Federal Government
Kenya: Ministry of Health

Keywords provided by United States Army Research Institute of Environmental Medicine:
diarrhea morbidity
malaria incidence
zinc supplementation

Additional relevant MeSH terms:
Diarrhea
Malaria
Signs and Symptoms, Digestive
Signs and Symptoms
Protozoan Infections
Parasitic Diseases
Zinc
Zinc Sulfate
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Astringents
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014