Results of a recent study by Yale University and the Mayo Clinic have raised concerns that Neocate formula may be causing rickets in infants and toddlers.

Neocate formula was created for children who cannot tolerate traditional formulas that are milk- or soy-based. Neocate contains proteins that are broken down into amino acids with the goal of preventing allergic reactions or symptoms of intolerance.

Nutricia North America manufactures Neocate, which is advertised as “hypoallergenic” and as “nutritionally complete.”

According to the Neocate website, the formula “is specially formulated for the dietary management of infants with cow milk allergy (CMA), multiple food allergies (MFA) and related GI and allergic conditions, including food protein-induced enterocolitis syndrome (FOIES), eosinophilic esophagitis (EoE) and gastroesophageal reflux (GER).”

Parents have recently become concerned about a risk of Neocate causing rickets or an increased risk of bone fractures, based on recent scientific research.

A recent study by Yale University and the Mayo Clinic published in the medical journal Bone said infants drinking Neocate formula tended to have low blood phosphate levels, a condition called hypophosphatemia. Such low phosphate levels can cause bones to deteriorate to a very low bone density, resulting in skeletal deformities and bones that break easily.

The possibility of Neocate causing rickets surprises parents who most often believe they are feeding their children complete nutrition. Rickets is most often caused by a lack of vitamin D and an insufficient consumption of calcium. It can result from any condition that impairs bone health, though is unusual for a lack of phosphorus to be linked to rickets.

The study found that 94 percent of 51 children who had been fed Neocate infant formula as their primary food source had rickets, broken bones or low phosphate levels.

Is Neocate Causing Rickets?

In 2002, researchers determined that phosphorous is as integral to well-developed bone strength as is calcium.

Research indicates the phosphate in Neocate is not bio-available to the children eating the amino acid-based formula as their primary source of food. This means that although Neocate appears to have adequate phosphate, children are not absorbing it well when they consume Neocate.

Those concerned about Neocate causing rickets also are asking what can be done to strengthen the bones of these children. Most children’s bone density and skeletal abnormalities improved when they switched to a different formula.

Neocate formulas include the following different products:

• Neocate Syneo Infant
• Neocate Infant DHA/ARA
• Neocate Nutra
• Neocate Junior
• Neocate Junior with Probiotics
• Neocate Splash

The website also indicates Neocate Syneo Infant formula is a medical food that should be used under medical supervision, but it appears the products may be ordered without a prescription.

A baby suffering from rickets is apt to exhibit floppy limbs, uncontrolled muscle spasms, bones that break easily and a condition known as Harrison’s groove, which is the appearance of a horizontal line on the child’s chest where the diaphragm is attached to the ribs.

Toddlers might appear bow-legged or knock-kneed, complain of bone pain, exhibit small stature, and be underweight. Blood tests will show low calcium levels in the blood.

Children with severe cases of rickets can experience cramps, seizures and problems breathing. In some cases, rickets can cause heart muscles to weaken.