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

NCT01166815 | Completed Phase 2 DMC

• 3 other identifiers: USARIEM C07-04WRAIR 1332KEMRI 1332
• Study Type: interventional
• Target: 500
• Locations: 2 countries
• Sites: 3

Brief 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

Keywords

diarrhea morbidity; malaria incidence; zinc supplementation

Outcome Measures

Primary Outcomes (1)

• Determine the incidence of diarrhea in zinc vs. placebo-supplemented adults

  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.

  Daily, for 104 days

Secondary Outcomes (3)

• Determine the time to diarrhea onset in both groups

  Daily, for 104 days

• Determine the duration of each diarrhea episode in both groups

  Daily, for 104 days

• Determine the number of loose stools/day/episode of diarrhea in both groups

  Daily, for 104 days

Study Arms (2)

Zinc supplemented

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Zinc sulphate DIETARY_SUPPLEMENT

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.

Zinc supplemented

Placebo OTHER

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

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• United States Army Research Institute of Environmental Medicine: lead
• Walter Reed Army Institute of Research (WRAIR): collaborator

Study Sites (3)

U.S. Army Research Institute of Environmental Medicine (USARIEM)

Natick, Massachusetts, 01760, United States

Location

U.S. Department of Agriculture, Agricultural Research Service, Grand Forks Human Nutrition Center

Grand Forks, North Dakota, 56721, United States

Location

Kombewa Clinical Research Center

Kombewa, Kisumu West, Kenya

Location

Related Publications (4)

• Scrimgeour AG, Lukaski HC. Zinc and diarrheal disease: current status and future perspectives. Curr Opin Clin Nutr Metab Care. 2008 Nov;11(6):711-7. doi: 10.1097/MCO.0b013e3283109092.

  PMID: 18827574 BACKGROUND

• Scrimgeour AG, Condlin ML. Zinc and micronutrient combinations to combat gastrointestinal inflammation. Curr Opin Clin Nutr Metab Care. 2009 Nov;12(6):653-60. doi: 10.1097/MCO.0b013e3283308dd6.

  PMID: 19684516 BACKGROUND

• 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

  RESULT

• 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.

  RESULT

MeSH Terms

Conditions

Diarrhea; Malaria

Interventions

Zinc Sulfate

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Inorganic Chemicals; Zinc Compounds

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Stella K Apollo, BSN

  Walter Reed Project (WRP), Kisumu, Kenya

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED

Study Record Dates

• First Submitted: July 19, 2010
• First Posted: July 21, 2010
• Study Start: July 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: July 22, 2010

Record last verified: 2010-07

Locations

US (2); KE (1)