Clinical Trial: Lysine Trial in Adults With Diarrhoea

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Efficacy of Lysine Supplementation in Reducing Attack Rates of Diarrhea in Adults: a Community-based Randomized Trial in Urban Bangladesh

Brief Summary:

Diarrhea as of today is still a major problem in developing world with high morbidity. Though mortality in under-5 children has declined over the years, diarrhea was responsible for 2.5 million deaths per year in developing countries. A median of 3.2 episodes of diarrhea in under-5 children per child-year has been estimated in developing countries. In Bangladesh, the overall prevalence of diarrhea was estimated to be about 2% for the entire population. However, a recent survey in 2003 with urban slum mothers indicated that the prevalence of diarrhea ranged from 0.7-4.1% in six divisional cities with 0.7% in Dhaka slum areas. Malnutrition remains the major adverse prognostic indicator for diarrhea related morbidity, which emphasizes importance of nutrition in early management. Repeated episodes of diarrhea are a frequent cause and consequence of malnutrition. To improve diarrhea situation in Bangladesh and elsewhere, interventions are directed to reduce mortality and morbidity through improvement of breast-feeding practices, complementary feeding, sanitation, increase in measles immunization rates, micronutrient supplementation, and oral rehydration therapy.

L-lysine, an essential amino acid, is required for healthy growth, tissue repair and enzyme production. It is a protein-building block that strengthens and nourishes the structural, circulatory and immune systems. It is not produced by the body like other essential amino acids and must be obtained from the diet. Some natural food sources for L-lysine include Lima beans, kidney beans, potatoes, corn, red meat, fish and milk. The mean requirement of lysine in healthy human adults is about 30 mg/kg body weight/day or 50 mg/g protein intake. Studies have shown that lysine therapy improves immune status and is used as a therapeutic agent in herpes simplex viral infection. A double-blind randomized trial of L-lysine treatmen

Detailed Summary:
Sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh

Current Primary Outcome: incidence/attack rate of diarrhea among the subjects over the six-month period of lysine supplementation [ Time Frame: 6 months ]

Primary outcome variable will be a decrease in incidence/attack rate of diarrhea among the subjects over the six-month period of lysine supplementation.


Original Primary Outcome: Same as current

Current Secondary Outcome: diarrheal duration and severity assessed by a clinical score [ Time Frame: 6 months ]

Secondary outcome variables will include diarrheal duration and severity assessed by a clinical score. Changes in immunological parameters including C3, total T-cell population, T-cell subset (CD4, CD8), natural killer cells as well as C-reactive protein and hemoglobin over time will also be assessed as outcome variables


Original Secondary Outcome: Same as current

Information By: International Centre for Diarrhoeal Disease Research, Bangladesh

Dates:
Date Received: May 18, 2014
Date Started: December 2005
Date Completion:
Last Updated: May 20, 2014
Last Verified: May 2014