Upper limit of vitamin E in infant formulas

Area of Science:

• Pediatrics
• Nutritional Science
• Neonatology

Background:

• Vitamin E toxicity in infants is uncommon but linked to sepsis and necrotizing enterocolitis.
• Elevated plasma vitamin E levels (>3.5 mg/dl) are associated with adverse outcomes.
• These high levels are rarely achieved with typical enteral vitamin E intake.

Purpose of the Study:

• To determine safe vitamin E intake levels for infants.
• To establish recommended vitamin E content in infant formulas.
• To ensure infant safety regarding vitamin E supplementation.

Main Methods:

• Review of reported cases of vitamin E toxicity in infants.
• Analysis of vitamin E intake thresholds associated with adverse events.
• Comparison of proposed formula fortification levels with physiological levels.

Main Results:

• Enteral vitamin E intake below 25 mg d-alpha-tocopherol equivalent/(kg.d) is generally safe.
• Infant formulas can provide up to 20 mg/100 kcal (30 IU/100 kcal) of vitamin E safely.
• A recommended manufacturing limit for added vitamin E in formula is 10 mg/100 kcal (15 IU/100 kcal).

Conclusions:

• A maximum vitamin E intake of 25 mg/kg/day is suggested for infants.
• Fortifying infant formula with 10 mg/100 kcal (15 IU/100 kcal) of vitamin E ensures safety.
• This level aligns with vitamin E concentrations in human colostrum.