Fluoride content in breast milk after the use of fluoridated food supplement. A randomized clinical trial

PURPOSE: To evaluate if the intake of a fluoridated food supplement in breastfeeding mothers increases the fluoride concentration in breast milk. METHODS: A double-blind randomized placebo-controlled study was designed. Two groups of women were formed: a fluoride group (n = 112), using a non-sucrose food supplement containing fluoride (1,500 μg/l for each dose) and a control group (n = 116), using a non-sucrose food supplement without fluoride content. The women were followed for 6 weeks. Samples of breast milk were collected and analyzed using an ion-specific electrode. RESULTS: 85 women in the fluoride group and 83 in the control group concluded the trial. Fluoride concentrations in the two groups were statistically significantly different (515 μg/l in the fluoride and 476 μg/l in the control group P= 0.04) at the end of the experimental period. In the fluoride group, a statistically significant increment in fluoride concentration during the experimental period was also observed (from 468 ± 104 μg/l to 515 ± 105 μg/l). The use of a non-sucrose food supplement containing fluoride resulted in a significant increment in fluoride concentration in breast milk.