Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Effect of Zinc Supplementation on the Immune and Inflammatory Responses of Children to Shigella Flexneri Infection, and Correlation With Clinical Severity of Illness and Growth Following recoveryEffect of Zinc Supplementation on the Immune and Inflammatory Responses of Children to Shigella Flexneri Infection, and Correlation With Clinical Severity of Illness and Growth Following Recovery
Brief Summary: Shigellosis is a major cause of morbidity and mortality in young children in Bangladesh and other developing countries. Further, the increasing emergence of resistance to a wide range of antibiotics is of great concern. Another major public health problem in Bangladesh is malnutrition, which is closely linked with shigellosis and with a high mortality. In Shigellosis, a heavy nutritional burden is placed on children and vital micronutrients such as vitamin A is lost in the urine. We recently found that the immune response in S. Flexneri infection was lower in children who were severely malnourished (weight-for-age≤65% as a percentage of the National Centre for Health Statistics median) when compared to children with weight-for-age from \>65-75%. T cell responses were primarily affected with lowered CD4/CD8 ratios, lowered proliferative responses to T cell mitogens, Conconavalin A (ConA) and phytohaemagglutinin (PHA). However, proliferation of pheripheral blood mononuclear cells (PBMs) was lowered only in the presence of autologous plasma suggesting that a factor(s) in plasma, probably nutritional, rather than a defect in cells themselves was responsible. In children with S. dysenteriae 1 infection, proliferative responses to PHA were similarly lowered in the presence of autologous plasma but inhibition correlated to lowered transferring levels in plasma and not to the weight-for-age of the children. Also severely malnourished children with either S. flexneri or S. dysenteriae 1 infection were more severely ill. These findingings show that immunity in malnourishrd children with shigella infection is impaired which may lead to more severe illness. As zinc has profound effects on immunity as well as clinical outcome in diarrhoeal diseases, it is possible that zinc deficiency may be a factor in reducing immunity and increasing severity of acute illness in malnourished children with shigellosis. In this study, we will investigate the effect of zinc supplementation, in a double blind placebo controlled trial, on inflammatory responses, outcome of acute illness and growth following recovery from acute illness with S. flexneri infection.


Options:
A: Intervention Type: DRUG; Name: Children in the zinc group received 20 mg of elemental zinc as acetate per day in a twice-daily dose for two weeks.; Assigned to Arm(s): N/A
B: Arm Label: Daily preventive Zn; placebo treatment; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Daily preventive Zn; placebo treatment | Arm Label: Therapeutic Zn; daily placebo; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Therapeutic Zn; daily placebo | Arm Label: Intermittent Zn; placebo treatment; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Intermittent Zn; placebo treatment | Arm Label: Surveillance control group; Type: ACTIVE_COMPARATOR; Interventions: Other: Surveillance control group | Arm Label: Non-intervention; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DIETARY_SUPPLEMENT; Name: Daily preventive Zn; placebo treatment; Assigned to Arm(s): Daily preventive Zn; placebo treatment | Intervention Type: DIETARY_SUPPLEMENT; Name: Therapeutic Zn; daily placebo; Assigned to Arm(s): Therapeutic Zn; daily placebo | Intervention Type: DIETARY_SUPPLEMENT; Name: Intermittent Zn; placebo treatment; Assigned to Arm(s): Intermittent Zn; placebo treatment | Intervention Type: OTHER; Name: Surveillance control group; Assigned to Arm(s): Surveillance control group
C: Intervention Type: DRUG; Name: ZINC; Assigned to Arm(s): N/A
D: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: Zinc and vitamin A single dose at enrollment | Arm Label: 2; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo and vitamin A single dose at enrollment | Intervention Type: DRUG; Name: Zinc and vitamin A single dose at enrollment; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Placebo and vitamin A single dose at enrollment; Assigned to Arm(s): 2

Answer: A