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Bulging fontanelle after supplementation with 25,000 IU of vitamin A in infancy using immunization contacts
A H Baqui1, A de Francisco, S E Arifeen
1International Centre for Diarrhoeal Disease Research, Bangladesh.
Insights
High-dose vitamin A supplementation in infants, particularly with repeated doses, may increase the risk of bulging fontanelle. This finding suggests a potential safety concern during early infancy immunization schedules.
Area of Science:
- Pediatrics
- Nutritional Science
- Public Health
Background:
- Vitamin A is crucial for infant development and immune function.
- Early infancy is a critical period for growth and susceptibility to infections.
- Immunization programs provide opportunities for targeted nutritional interventions.
Purpose of the Study:
- To assess the safety of vitamin A supplementation in infants during routine immunization.
- To investigate potential adverse events associated with high-dose vitamin A in early life.
- To evaluate the relationship between vitamin A dosage and specific side effects.
Main Methods:
- A double-blind, randomized, placebo-controlled trial was conducted in Bangladesh.
- 167 infants received three doses of 25,000 IU vitamin A or placebo alongside DPT/OPV immunizations.
- Infants were monitored by physicians for adverse events, including fontanelle bulging, post-supplementation.
Main Results:
- Nine infants (10.5%) receiving vitamin A experienced bulging fontanelle, compared to two (2.5%) in the placebo group (p < 0.05).
- Most episodes (12/14) occurred in the vitamin A group, with increasing frequency after the second and third doses.
- A cumulative effect was suggested, as more doses correlated with a higher likelihood of bulging fontanelle.
Conclusions:
- Vitamin A supplementation in early infancy, especially with multiple doses, may be associated with an increased incidence of bulging fontanelle.
- The findings suggest a potential causal link and cumulative effect of vitamin A on this specific adverse event.
- Further research is warranted to clarify the safety profile and optimal dosing of vitamin A in infants during immunization programs.
Abstract:
To evaluate the safety of vitamin A supplementation in early infancy using DPT/OPV immunization contracts, a double-blind, randomized, placebo-controlled trial was conducted in Bangladesh. One hundred and sixty-seven infants received three doses of either 25,000 IU of vitamin A or a placebo at about 6.5, 11.8 and 17.0 weeks of age. Trained physicians examined each of the infants on days 1, 2, 3 and 8 after supplementation. Nine infants (10.5%) supplemented with vitamin A had episodes of bulging of the fontanelle compared with two infants (2.5%) in the placebo group (p < 0.05). Twelve of the 14 episodes occurred in infants supplemented with vitamin A. Of these 12 episodes, none occurred with the first dose, 3 occurred with the second and 9 with the third dose. The higher incidence of bulging of the fontanelle in the vitamin A group relative to the placebo group and its temporal association with the vitamin A doses are suggestive of a causal association. The finding that increased numbers of vitamin A doses were associated with a higher probability of bulging of the fontanelle suggests a cumulative effect.