Iron-Fortified Formula for Infant Development

Recruiting at 39 trial locations

Overseen By Patrick McCarthy, JD

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Aussie Bubs, Inc.

Disqualifiers: Health conditions impacting feeding

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 16 weeks

440 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial studies the effects of a special baby formula on the growth of healthy infants over a few months. The goal is to see if the added nutrients help babies gain weight and develop normally. Babies will be fed as much formula as they want during this period. The American Academy of Pediatrics has strongly advocated nutrient fortification of infant formulas since 1969 to reduce the prevalence of iron-deficiency anemia.

Do I need to stop my baby's current medications for the trial?

The trial protocol does not specify if you need to stop your baby's current medications.

Do I need to stop my baby's current medications for the trial?

The trial information does not specify whether infants need to stop taking any current medications.

What data supports the idea that Iron-Fortified Formula for Infant Development is an effective treatment?

The available research shows that iron-fortified soy formula is as effective as iron-fortified cow's milk formula in preventing iron deficiency in infants. In a study, infants fed with soy formula and those fed with iron-fortified cow's milk had similar levels of important blood components related to iron status. Only a small percentage of infants on these formulas developed anemia compared to a much higher percentage in breast-fed infants. This suggests that iron-fortified formulas are effective in maintaining healthy iron levels in infants. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Iron-Fortified Formula for Infant Development?

Research shows that soy formula, despite lower iron absorption in adults, is as effective as iron-fortified cow's milk in preventing iron deficiency in infants, with low rates of anemia compared to breast-fed infants. ^{1 2 3 4 5}

What safety data exists for iron-fortified infant formulas?

The safety of iron-fortified infant formulas, including those under various brand names like Similac and Isomil, has been evaluated in several studies. One study found that Similac Special Care may not deliver the expected amounts of calcium, iron, and zinc during continuous feeding. Soya-based infant formulas (SIF) have been reviewed for safety, showing similar growth, bone health, and metabolic functions compared to cow's milk formulas (CMF) and human milk (HM), despite higher levels of phytates and aluminum. Another study comparing a new Israeli soy formula with Isomil found no significant differences in safety or efficacy. Overall, modern SIFs are considered safe for children with specific nutritional needs, but close monitoring is recommended, especially in cases of renal disease. ^{2 4 6 7 8}

Is iron-fortified infant formula safe for infants?

Research shows that soy-based infant formulas, which are sometimes used as alternatives to cow's milk formulas, are generally safe for infants. They support normal growth, bone health, and immune function, similar to other infant formulas. However, close monitoring is recommended, especially for infants with specific health conditions. ^{2 4 6 7 8}

Is the treatment Infant Formula a promising treatment for infant development?

Yes, the iron-fortified infant formula is promising for infant development. It effectively prevents iron deficiency, similar to cow's milk formula, and supports healthy growth in infants. ^{1 3 4 6 9}

How does the iron-fortified infant formula treatment differ from other treatments for infant development?

The iron-fortified infant formula, including soy-based options like Prosobee, is unique because it provides essential iron to infants, which is crucial for preventing iron deficiency, despite having lower iron absorption rates in adults. This formula is as effective as cow's milk-based formulas in maintaining healthy iron levels in infants, making it a suitable alternative for those with cow's milk allergies or lactose intolerance. ^{1 3 4 6 9}

Research Team

Keith Aqua, MD

Principal Investigator

Backtee Holdings, LLC

Eligibility Criteria

This trial is for healthy babies born at full term. It's not suitable for infants with health issues that could affect how they feed or grow.

Inclusion Criteria

My baby was born at full term and is healthy.

Exclusion Criteria

Any health condition that would negatively impact infant feeding and growth.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Infants are fed iron-fortified infant formulas ad-libitum and monitored for growth and tolerance

16 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Infant Formula

Trial Overview The study tests the growth effects of iron-fortified infant formula over a period of 4 months, monitoring weight gain and overall development in these infants.

Participant Groups

Group I: Study Formula 3_Cow's Milk Infant Formula void of A1-BetaCasein Experimental Treatment 1 Intervention

Infant Formula meets all nutrient requirements of the FDA.

Group II: Study Formula 2_Goat Milk Infant Formula Experimental Treatment 1 Intervention

Infant Formula meets all nutrient requirements of the FDA.

Group III: Study Formula 1_365 Day Grass-Fed Cow's Milk Infant Formula Experimental Treatment 1 Intervention

Infant formula meets all nutrient requirements of the FDA.

Group IV: Study Formula 4_USDA Organic iron fortified infant formula Active Control 1 Intervention

Infant Formula meets all nutrient requirements of the FDA.

Infant Formula is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Infant Formula for:

• Nutritional supplement for infants

Approved in European Union as Infant Formula for:

• Nutritional supplement for infants

Approved in Canada as Infant Formula for:

• Nutritional supplement for infants

Who Is Running the Clinical Trial?

Aussie Bubs, Inc.

Lead Sponsor

Trials

1

Recruited

440+

Validcare CRO

Collaborator

Findings from Research

In a study involving 16 adult women, iron absorption from a soy formula was found to be very low at only 1.7%, indicating that soy products may inhibit iron absorption.

Despite this low absorption rate in adults, a study of 47 infants showed that those fed soy formula had similar iron nutritional status and low anemia rates compared to those fed iron-fortified cow's milk, suggesting that soy formula can effectively prevent iron deficiency in infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bioavailability of iron in soy-based formula and its effect on iron nutriture in infancy. Hertrampf, E., Cayazzo, M., Pizarro, F., et al.[2023]

A case study of a 9-month-old infant with renal disease showed that using Renastart pediatric renal formula alongside expressed breast milk improved growth and maintained normal serum electrolyte levels, indicating its efficacy for infants with renal impairment.

The study highlights the importance of monitoring protein intake and electrolytes when using Renastart, suggesting that phosphorus supplementation may be necessary, and calls for larger studies to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Renastart Use in an Infant on Peritoneal Dialysis. Keung, LG.[2019]

Both milk-based, iron-fortified formulas containing 7.4 mg/L and 12.7 mg/L of iron support normal growth and iron status in healthy infants during their first year, as shown in a study of 347 infants, with 172 included in the final analysis.

There were no significant differences in growth, formula tolerance, or iron levels between the two formula groups, indicating that both iron levels are effective and well-tolerated options for infants who are not breast-fed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of two iron-fortified, milk-based formulas during infancy. Bradley, CK., Hillman, L., Sherman, AR., et al.[2013]

A study involving 45 infants aged 1-6 months found that the new Israeli soy formula, Materna Tsimchit, is as effective as the well-known Isomil formula in managing cow-milk allergy and lactose intolerance over a 2-month period.

No significant differences were observed between the two formulas in terms of compliance, behavior, growth parameters, and overall health assessments, suggesting that Materna Tsimchit is a viable alternative to Isomil.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evaluation of a new Israel infant soy formula]. Weizman, Z.[2023]

In a study involving 967 healthy infants, the new infant formula (NF) was found to be well tolerated, showing stool consistencies that were softer than those of other marketed formulas (OF) and more similar to those of infants fed human milk (HM).

There were no significant differences in gastrointestinal intolerance symptoms among the different feeding regimens, indicating that all formulas, including NF, were well tolerated by the infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gastrointestinal tolerance of a new infant milk formula in healthy infants: multicenter study conducted in Taiwan. Chen, N., Alarcon, PA., Comer, GM., et al.[2019]

In a study examining the stability of vitamins and minerals in the Similac Special Care formula for premature infants, significant reductions in calcium (44-54%), iron (23-34%), and zinc (18-32%) were observed after continuous infusion, indicating that infants may not receive the expected amounts of these nutrients.

In contrast, another formula, Similac 24LBW, showed stable concentrations of all vitamins and minerals tested, suggesting that it may be a more reliable option for ensuring nutrient delivery in premature infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stability of vitamin and mineral concentrations of a low-birth-weight infant formula during continuous enteral feeding. Antonson, DL., Smith, JL., Nelson, RD., et al.[2019]

Soya-based infant formulas (SIF) have been found to support growth and bone health in children similarly to cow's milk-based formulas (CMF) and human milk (HM), despite concerns about their safety.

The study showed no significant negative effects on reproductive, endocrine, immune, or cognitive functions in children fed SIF compared to those fed CMF or HM, indicating that modern SIF can be a safe alternative for infants with specific dietary needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of soya-based infant formulas in children. Vandenplas, Y., Castrellon, PG., Rivas, R., et al.[2014]

Soy infant formulas (SIF) are effective for managing cow's milk allergy and have a low risk of cross-allergy, making them a suitable alternative for infants with specific dietary needs.

SIFs demonstrate a good safety profile and offer advantages in cost, taste, and positive effects on gut microbiota, although evidence for their use in functional digestive disorders is limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Recomendaciones sobre la utilización de las fórmulas infantiles con proteína aislada de soya en la alimentación del lactante. Documento de posición basado en la evidencia]. Gutiérrez-Castrellón, P., Vázquez-Frías, R., Jiménez-Gutiérrez, C., et al.[2023]

Preterm infants fed Similac With Iron showed better absorption and retention of calcium, phosphorus, and zinc compared to those fed Similac With Whey + Iron, which is crucial for their growth and development.

Despite the benefits of both formulas, the retention of essential minerals like calcium, phosphorus, and zinc was still inadequate to meet the estimated fetal requirements, highlighting a risk for deficiencies in preterm infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrient retention in preterm infants fed standard infant formulas. Cooke, RJ., Nichoalds, G.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Bioavailability of iron in soy-based formula and its effect on iron nutriture in infancy. [2023]

2. Canada pubmed.ncbi.nlm.nih.gov

Renastart Use in an Infant on Peritoneal Dialysis. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Evaluation of two iron-fortified, milk-based formulas during infancy. [2013]

4. Israel pubmed.ncbi.nlm.nih.gov

[Evaluation of a new Israel infant soy formula]. [2023]

5. China pubmed.ncbi.nlm.nih.gov

Gastrointestinal tolerance of a new infant milk formula in healthy infants: multicenter study conducted in Taiwan. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Stability of vitamin and mineral concentrations of a low-birth-weight infant formula during continuous enteral feeding. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Safety of soya-based infant formulas in children. [2014]

8. Mexico pubmed.ncbi.nlm.nih.gov

[Recomendaciones sobre la utilización de las fórmulas infantiles con proteína aislada de soya en la alimentación del lactante. Documento de posición basado en la evidencia]. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Nutrient retention in preterm infants fed standard infant formulas. [2019]