Iron-Fortified Formula for Infant Development
Recruiting in Palo Alto (17 mi)
+39 other locations
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Aussie Bubs, Inc.
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 3 Jurisdictions
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.
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.
12345What 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.
24678Eligibility 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.
Participant Groups
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.
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.
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Kentucky Pediatric ResearchBardstown, KY
Helios Clinical Research-HoustonHouston, TX
Clintheory Healthcare MiamiNorth Miami Beach, FL
Hightower ClinicalShawnee, OK
More Trial Locations
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Who Is Running the Clinical Trial?
Aussie Bubs, Inc.Lead Sponsor
References
Bioavailability of iron in soy-based formula and its effect on iron nutriture in infancy. [2023]Soy products have been reported to inhibit absorption of nonheme food iron and fortification iron. Iron bioavailability from a soy formula (Prosobee-PP 710) (iron added as ferrous sulfate: 12 mg/L; ascorbic acid: 54 mg/L) was examined in 16 adult women using the extrinsic radioactive tag method. The geometric mean absorption from the soy formula was only 1.7%. The effect of this formula on iron nutrition in infants was studied in 47 healthy term infants weaned spontaneously before 2 months of age and who received the formula ad libitum until 9 months of age. For control, 45 infants received a cow's milk formula fortified with ferrous sulfate (iron: 15 mg/L; ascorbic acid: 100 mg/L), which has been shown to be effective in preventing iron deficiency, and 49 additional breast-fed infants were also followed. All babies received solid foods (vegetables and meat) starting at 4 months of age. Iron nutritional status was determined at 9 months. Infants fed soy formula and iron-fortified cow's milk had similar mean values of hemoglobin, mean corpuscular volume, transferrin saturation, free erythrocyte protoporphyrin, and serum ferritin; both formula groups differed significantly (P less than .05) from the breast-fed group in all measurements except free erythrocyte protoporphyrin. Anemia (hemoglobin less than 11 g/dL) was present in only 4.3% and 2.2% of infants receiving the soy and the fortified formulas, respectively, v 27.3% in the breast-fed group. These results indicate that soy formula, in spite of the lower iron bioavailability when measured in adults, is essentially as effective as iron-fortified cow's milk in preventing iron deficiency in infants.
Renastart Use in an Infant on Peritoneal Dialysis. [2019]Adequate nutrition and growth is vital in pediatrics. Breast milk alone might not be able to satisfy the nutrition needs of an infant with renal disease. Similac PM 60/40 (Abbott Laboratories, Abbott Park, IL, U.S.A.) is a low-iron infant formula indicated for infants who would benefit from a lowered mineral intake. It is the only infant formula marketed in the United States for infants with renal impairment. The objective of the present case study was to examine whether Renastart, a pediatric renal formula (Nestlé Health Science, Florham Park, NJ, U.S.A.), could be used alongside expressed breast milk (EBM) to meet the nutritional needs of an infant with renal disease, while maintaining normal serum electrolytes.A 9-month-old infant received EBM with Similac PM 60/40 treated with Kayexalate (Concordia Pharmaceuticals, Bridgetown, Barbados) because of hyperkalemia. That formulation was not well tolerated, and the infant's growth trajectory declined. The infant was then switched to EBM with Renastart. During this intervention, growth trends; formula volume; kilocalories and protein grams consumed per kilogram weight; episodes of emesis; serum Na, K+, Ca, and phosphorus; blood urea nitrogen; and creatinine were collected.Results showed an increase of formula intake, an improvement in weight and linear growth, and normal serum levels of Na, K+, and Ca, but low serum phosphorus.A combination of Renastart and EBM can be safely and effectively used to meet the needs of an infant with renal disease. Close monitoring of protein intake and electrolytes is necessary, and supplementation with phosphorus should be considered. Larger studies are needed to further confirm the benefits of Renastart in infants.
Evaluation of two iron-fortified, milk-based formulas during infancy. [2013]Compare milk-based, iron-fortified formulas containing 7.4 and 12.7 mg/L iron and breast-feeding during the first year of life.
[Evaluation of a new Israel infant soy formula]. [2023]A new infant soy formula has recently been developed in Israel and is being produced (Materna Tsimchit, Trima Industries, Kibbutz Ma'aborot). We compared its efficacy with that of a well-known imported soy formula (Isomil, Ross Laboratories, USA) in a prospective, randomized, double-blind study. 45 normal infants, aged 1-6 months, were monitored for over 2 months after the soy formula was started either because of cow-milk allergy or lactose intolerance. 22 received Materna Tsimchit and 23 Isomil. The study revealed no significant differences between the products with regard to compliance, behavior, symptoms, physical examination (including growth parameters and nutritional assessment), stool characteristics and complete blood counts. We conclude, given the limitations of the present study, that the new Israeli product is as effective as the foreign product.
Gastrointestinal tolerance of a new infant milk formula in healthy infants: multicenter study conducted in Taiwan. [2019]The objective of this study was to test whether the gastrointestinal tolerance of a new infant formula equalled or exceeded the tolerance of other milk-based infant formulas, and to compare the tolerance of the new formula to that of human milk. This prospective, observational, multicenter, open-label study was conducted in Taiwan. Healthy, full-term infants aged 28-98 days were enrolled on their current feeding regimen (no treatment assigned). Feeding regimens included human milk (HM), a new infant formula (NF, Similac Advance), other marketed infant formulas (OF, mainly Enfalac or S-26, HM + NF and HM + OF. Data for stool frequency, stool consistency and gastrointestinal intolerance symptoms were recorded in study diaries by parents for a period of two weeks. Gastrointestinal tolerance was evaluated in 967 infants, of whom 481 (49.7%) received NF, 312 (32.2%) received OF, 101 (10.4%) received HM + NF, 41 (4.2%) received HM + OF and 32 (3.3%) received HM. Infants fed HM only had softer and more frequent stools than those who received NF only or OF only (P
Stability of vitamin and mineral concentrations of a low-birth-weight infant formula during continuous enteral feeding. [2019]The stability of several vitamins and minerals of a new formula for premature infants, Similac Special Care, was examined following passage through a simulated continuous infusion apparatus designed to duplicate that used for continuous enteral feeding in infants. The concentrations of calcium, iron, zinc, copper, magnesium, vitamin A, vitamin C, and vitamin E were measured before and after infusion at rates appropriate for delivering 120 calories/kg to infants weighing 733 and 1,000 g. Following passage through this apparatus, significant reductions were noted for calcium (44-54%), iron (23-34%), and zinc (18-32%). Concentrations of copper, magnesium, and vitamins A, C, and E remained stable. When another formula commonly used for premature infants, Similac 24LBW, was subjected to similar analysis, the concentrations of all vitamins and minerals studied remained stable. Our study demonstrates that infants fed Similac Special Care by continuous infusion may not receive the quantity of calcium, iron, and zinc implied by the product label.
Safety of soya-based infant formulas in children. [2014]Soya-based infant formulas (SIF) containing soya flour were introduced almost 100 years ago. Modern soya formulas are used in allergy/intolerance to cows' milk-based formulas (CMF), post-infectious diarrhoea, lactose intolerance and galactosaemia, as a vegan human milk (HM) substitute, etc. The safety of SIF is still debated. In the present study, we reviewed the safety of SIF in relation to anthropometric growth, bone health (bone mineral content), immunity, cognition, and reproductive and endocrine functions. The present review includes cross-sectional, case-control, cohort studies or clinical trials that were carried out in children fed SIF compared with those fed other types of infant formulas and that measured safety. The databases that were searched included PubMed (1909 to July 2013), Embase (1988 to May 2013), LILACS (1990 to May 2011), ARTEMISA (13th edition, December 2012), Cochrane controlled trials register, Bandolier and DARE using the Cochrane methodology. Wherever possible, a meta-analysis was carried out. We found that the anthropometric patterns of children fed SIF were similar to those of children fed CMF or HM. Despite the high levels of phytates and aluminium in SIF, Hb, serum protein, Zn and Ca concentrations and bone mineral content were found to be similar to those of children fed CMF or HM. We also found the levels of genistein and daidzein to be higher in children fed SIF; however, we did not find strong evidence of a negative effect on reproductive and endocrine functions. Immune measurements and neurocognitive parameters were similar in all the feeding groups. In conclusion, modern SIF are evidence-based safety options to feed children requiring them. The patterns of growth, bone health and metabolic, reproductive, endocrine, immune and neurological functions are similar to those observed in children fed CMF or HM.
[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]Soy infant formulas (SIF) have long been used as an alternative for infants with special nutritional requirements. However, the medical indications for their use, their allergenicity, safety and efficacy are still controversial.
Nutrient retention in preterm infants fed standard infant formulas. [2019]Our purpose was to compare nitrogen, mineral, and zinc balance in preterm infants fed standard infant formulas, Similac With Iron and Similac With Whey + Iron. Nitrogen and magnesium balances were similar during both feeds, and met estimated fetal requirements. Infants absorbed and retained (milligrams per kilogram per day) more calcium, phosphorus, and zinc when fed Similac With Iron. However, retention of calcium, phosphorus (both formulas), and zinc (Similac With Whey + Iron) was inadequate to meet estimated fetal requirements. These findings are important in the rapidly growing preterm infant, who is already at risk for the development of rickets and zinc deficiency and may be fed either formula on discharge from the newborn nursery.