Neocate Formula is a hypoallergenic, amino acid formula given to infants and children who are allergic to cows-milk protein or who suffer from other conditions that cause an intolerance to regular formulas. However, a recent study has suggested that Neocate may be associated with serious side effects, including rickets, low phosphate levels, bone disease, and bone fractures.
Neocate is a line of amino acid formulas (also known as elemental formulas) manufactured by Nutricia, a Dutch company that specializes in baby food and clinical nutrition.
Neocate products are indicated for use in infants and children who suffer from:
Typical formulas contain whole proteins or protein fragments (hydrolysates) derived from either cow milk or soy. Neocate and other elemental formulas are made from free amino acids – protein in its simplest form – that can be more easily processed by the body.
Amino acid formulas are usually formulated either for infants 0–1 years of age or for children 1–10 years of age.
Neocate is one of the more popular brands of elemental formulas sold in the U.S. Other common brands include EleCare and Nutramigen Puramino.
The Neocate products available in the U.S. include:
A recent study has linked Neocate to a range of serious side effects, including:
The research, which was published in the April 2017 issue of the medical journal Bone, involved 51 children, all of whom were diagnosed with unexplained hypophosphatemia. Skeletal radiographs demonstrated fractures, undermineralization, or rickets in 94% of the cases.
Most children had been solely fed Neocate formula products for variable periods of time prior to presentation. Nearly all improved after they were treated with supplemental phosphate or changed to a different formula product.
“The widespread nature of the findings lead us to strongly recommend careful monitoring of mineral metabolism in children fed EF (elemental formula),” the authors of the study wrote. “Transition to alternative formula use or implementation of phosphate supplementation should be performed cautiously with as severe hypocalcemia may develop.”
The Neocate website available to U.K. consumers acknowledges this study and cautions that children who receive amino acid formulas “require regular monitoring and review and follow up is essential to ensure they receive adequate nutrition.”
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