Vitamin Information Center

Adverse Events
Definition
An adverse event (AE) is any adverse change in health
or “side-effect” that occurs in a person during a clinical
trial or within a pre-specified period after dosing of
a drug is complete. Not every adverse event is causally
related to the treatment being studied, but researchers
must report all adverse events to the relevant regulatory
authority in the country where the drug is to
be registered. Adverse events categorized as “serious”
(for example death, illness requiring hospitalization,
events deemed life-threatening, etc.) must be reported
to the regulatory authorities immediately, whereas
minor adverse events are merely documented in the
annual summary sent to the regulatory authority.
Cross-References
 Adverse Drug Reaction
 Adverse Effect
 Side Effect

Infants who get vitamin D supplements have a lower risk of getting type 1 diabetes, a small study suggests.

The study was not a clinical trial. Researchers Christos S. Zipitis, MBChB, of NHS Foundation Trust, and Anthony K. Akobeng, MBChB, combined data from five studies that looked for differences between kids who got type 1 diabetes and kids who did not.

The combined data suggest that giving infants vitamin D supplements cuts their risk of type 1 diabetes by 29%.

It’s not clear how vitamin D might fight diabetes. However, Zipitis and Akobeng note that insulin-making beta cells in the pancreas are sensitive to vitamin D.

Moreover, the body makes vitamin D in response to sunlight on the skin. The researchers note that infants in wintry Finland are 400 times more likely than a child in sunny Venezuela to have childhood diabetes.

The researchers note that randomized clinical trials will be needed to determine whether vitamin D truly helps prevent diabetes.

Pediatricians already recommend vitamin D supplements for children to prevent rickets. The American Academy of Pediatrics recommends that all infants, including those who are exclusively breastfed, have a minimum intake of 200 IU of vitamin D per day during the first two months of life. After that, daily intake of 200 IU of vitamin D per day is recommended throughout childhood and adolescence.

Zipitis and Akobeng report their findings in the online edition of Archives of Diseases in Childhood.