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September 22, 1989

Ethics of a Randomized Trial of Periconceptual Vitamins

Author Affiliations

National Institute of Hygiene Budapest, Hungary

National Institute of Hygiene Budapest, Hungary

JAMA. 1989;262(12):1634. doi:10.1001/jama.1989.03430120083026

To the Editor.—  We would like to comment on the article by Mulinare et al.1 In Hungary, we are also trying to test the efficacy of periconceptional multivitamin supplementation2 in the reduction of first occurrences of neural tube defects.3 At the first visit, women seeking family planning are informed about the purpose of multivitamin use. Those who agree are asked to sign a form of consent and instructed to take capsules for 1 month before planned conception and for 3 months after the last menstrual period.

Study.—  In a double-blind study, a single capsule of vitamins and minerals (Elevit Pronatal) or placebo is taken each day. The composition of the capsule of vitamins and minerals is as follows: vitamin A, 6000 IU; thiamine hydrochloride (vitamin B1), 1.6 mg; riboflavin (vitamin B2), 1.8 mg; niacinamide (nicotinamide), 19.0 mg; pyridoxine hydrochloride (vitamin B6), 2.6 mg; calcium