What is the mechanism of action of this treatment?

Iron-fortified infant formulas work by providing essential nutrients, particularly iron, which is vital for the production of hemoglobin and oxygen transport in the blood. Adequate iron levels are crucial for cognitive and psychomotor development in infants. These formulas help prevent iron deficiency anemia, which can lead to developmental delays and impaired growth. By ensuring sufficient iron intake, iron-fortified formulas support overall growth, brain development, and the prevention of developmental issues in infants.

What side effects are associated with this type of intervention?

Iron-fortified infant formulas are generally well-tolerated, but some infants may experience gastrointestinal issues such as constipation or diarrhea. Prebiotics and probiotics, commonly added to infant formulas to promote gut health, have a good safety profile with few side effects, though there is a theoretical risk of promoting pathogen growth in preterm infants. Vitamin supplementation, such as vitamin D, is also typically safe but should be monitored to avoid hypervitaminosis. Overall, these treatments are considered safe with minimal adverse effects when used appropriately.

What prior FDA approvals exist?

The FDA has approved various iron-fortified infant formulas designed to support healthy growth and development in infants. These formulas provide essential nutrients, including iron, which is crucial for preventing iron deficiency anemia and supporting cognitive and physical development. Notable FDA-approved iron-fortified formulas include Enfamil, Similac, and Gerber Good Start, which are widely used to ensure infants receive adequate iron intake during critical growth periods.

What other types of research exist?

Promising novel alternatives to iron-fortified infant formula for infant development include: 1) Hydrolyzed protein formulas, which are easier to digest and may reduce the risk of allergies. 2) Probiotic-enriched formulas, which support gut health and immune function. 3) Formulas with added long-chain polyunsaturated fatty acids (LCPUFAs), such as DHA and ARA, which are important for brain and eye development. 4) Organic and non-GMO formulas, which may appeal to parents seeking natural options. 5) Formulas with enhanced bioavailability of iron and other micronutrients, ensuring better absorption and utilization by the infant's body.

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Iron-Fortified Formula for Infant Development

Phase 3

Recruiting

Led By Keith Aqua, MD

Research Sponsored by Aussie Bubs, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 16 weeks of clinical study

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly stated, potential side effects may include digestive discomfort or allergic reactions to ingredients in the formula.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 16 weeks of clinical study

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~16 weeks of clinical study

This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks of clinical study for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Weight gain (g) from study entry to 16 weeks of study.

Secondary study objectives

Head Circumference gain (cm) from study entry to 16 weeks of study

Recumbent length gain (cm) from study entry to 16 weeks of study.

Tolerance of study formulas over 16 weeks of study

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Study Formula 3_Cow's Milk Infant Formula void of A1-BetaCaseinExperimental Treatment1 Intervention

Infant Formula meets all nutrient requirements of the FDA.

Group II: Study Formula 2_Goat Milk Infant FormulaExperimental Treatment1 Intervention

Infant Formula meets all nutrient requirements of the FDA.

Group III: Study Formula 1_365 Day Grass-Fed Cow's Milk Infant FormulaExperimental Treatment1 Intervention

Infant formula meets all nutrient requirements of the FDA.

Group IV: Study Formula 4_USDA Organic iron fortified infant formulaActive Control1 Intervention

Infant Formula meets all nutrient requirements of the FDA.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Iron-fortified infant formulas work by providing essential nutrients, particularly iron, which is vital for the production of hemoglobin and oxygen transport in the blood. Adequate iron levels are crucial for cognitive and psychomotor development in infants. These formulas help prevent iron deficiency anemia, which can lead to developmental delays and impaired growth. By ensuring sufficient iron intake, iron-fortified formulas support overall growth, brain development, and the prevention of developmental issues in infants.

[Treatment of anemia in pregnancy].A Randomized controlled trial of the Effect of intraVenous iron on Anaemia in Malawian Pregnant women (REVAMP): Statistical analysis plan.Effect of chronic erythropoietin administration on plasma iron in newborn lambs.