Sepsis — Therapeutic Zinc in Infant Bacterial Illness
Citation(s)
Abdulla M, Suck C Blood levels of copper, iron, zinc, and lead in adults in India and Pakistan and the effect of oral zinc supplementation for six weeks. Biol Trace Elem Res. 1998 Mar;61(3):323-31.
Brown KH, Peerson JM, Rivera J, Allen LH Effect of supplemental zinc on the growth and serum zinc concentrations of prepubertal children: a meta-analysis of randomized controlled trials. Am J Clin Nutr. 2002 Jun;75(6):1062-71.
Cousins RJ, Leinart AS Tissue-specific regulation of zinc metabolism and metallothionein genes by interleukin 1. FASEB J. 1988 Oct;2(13):2884-90.
Mahalanabis D, Bhan MK Micronutrients as adjunct therapy of acute illness in children: impact on the episode outcome and policy implications of current findings. Br J Nutr. 2001 May;85 Suppl 2:S151-8.
Murray CJ, Lopez AD Global mortality, disability, and the contribution of risk factors: Global Burden of Disease Study. Lancet. 1997 May 17;349(9063):1436-42.
Prasad AS Effects of zinc deficiency on Th1 and Th2 cytokine shifts. J Infect Dis. 2000 Sep;182 Suppl 1:S62-8.
Schultink, W , Merzenich, M, Gross, R, Shrimpton, R, Dillon, D(1997). "Effects of iron-zinc supplementation on the iron, zinc, and vitamin A status of anamemic pre-school children. " Food and Nutrition Bulletin 18(4):311-16
Shankar AH, Prasad AS Zinc and immune function: the biological basis of altered resistance to infection. Am J Clin Nutr. 1998 Aug;68(2 Suppl):447S-463S. Review.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.