Problem: A recent study was conducted "to evaluate the efficacy of milk fortified with specific multiple micronutrients on morbidity in children compared with the same milk without fortification." Children aged 1-3 were randomly assigned to received fortified milk (N=316) or control milk (N=317) for one year. The study was double-blinded. One of the study outcome measures was incidence of diarrhea. Investigators reported a relative risk of 0.84 comparing the fortification group to the standard milk group. (Sazawal et al. Effects of fortified milk on morbidity in young children in north India: community based, randomized, double masked placebo controlled trial. BMJ, 2008)
Q1. Discuss how the results might have been affected if the comparison group was: (1) no milk instead of non-fortified milk; (2) milk fortified with other nutrients besides those being investigated in the study.
Q2. Do you see any ethical issues in this study in terms of equipoise?
Q3. Discuss the meaning of informed consent in vulnerable or underage populations. Can truly informed consent ever be obtained in these populations? How would you as a study investigator make sure that patients enrolled in the study were fully informed? What elements should go into an informed consent in this type of study?