Related Experiment Video

Updated: Nov 21, 2025

Optimized Procedure for Determining the Adsorption of Phosphonates onto Granular Ferric Hydroxide using a Miniaturized Phosphorus Determination Method
08:21

Optimized Procedure for Determining the Adsorption of Phosphonates onto Granular Ferric Hydroxide using a Miniaturized Phosphorus Determination Method

Published on: May 18, 2018

14.9K

Different elemental infant formulas show equivalent phosphorus and calcium bioavailability in healthy volunteers

Clemens Bergwitz1, Simone R B M Eussen2, Pilou L H R Janssens2

  • 1Yale University School of Medicine, Section of Endocrinology and Metabolism, New Haven, CT, USA.

Nutrition Research (New York, N.Y.)
|January 15, 2021
PubMed

Insights

This study found that two elemental infant formulas, Neocate and Elecare, demonstrate equivalent phosphorus and calcium bioavailability in healthy adults, even when taking acid-suppressive medication. This confirms their suitability for individuals requiring specialized nutrition.

Area of Science:

  • Clinical Nutrition
  • Human Metabolism
  • Pharmacokinetics

Background:

  • Hypophosphatemia is a risk with elemental formulas in children with complex conditions.
  • Elemental formulas are used for specialized nutritional support.
  • Gastric acid-suppressive medication can affect nutrient absorption.

Purpose of the Study:

  • To evaluate and compare the bioavailability of phosphorus from two commercial elemental formulas (Neocate and Elecare).
  • To assess the bioequivalence of these two products in healthy volunteers.
  • To determine if gastric acid-suppressive medication impacts phosphorus bioavailability from these formulas.

Main Methods:

  • A single-center, double-blind, randomized, cross-over study in healthy volunteers with esomeprazole-induced hypochlorhydria.
  • Subjects received a standardized low phosphorus meal followed by fasting, then consumed one of the two elemental formulas (1g phosphorus, 1217 kcal).
  • Blood and urine samples were collected over 6 hours to measure serum and urinary phosphate and calcium levels, assessing Area Under the Curve (AUC) and peak concentrations (Cpeak).

Main Results:

  • Serum phosphate bioavailability met bioequivalence criteria for both formulas (AUC0-360 GMR: 1.041, Cpeak GMR: 1.020).
  • Serum calcium bioavailability also demonstrated bioequivalence (AUC0-360 GMR: 1.002, Cpeak GMR: 0.991).
  • Urinary creatinine-corrected phosphate did not meet bioequivalence criteria, though calcium excretion did.

Conclusions:

  • Both Neocate and Elecare exhibit equivalent serum phosphorus and calcium bioavailability in healthy adults.
  • The findings support the use of these elemental formulas even in individuals taking acid-suppressive medication.
  • This study provides crucial data on the nutritional equivalence of these specialized infant formulas.

Keywords:
Amino acid-based formulaCow's milk allergyCross-over studyNeocatePhosphate

More Related Videos

The Caco-2 Cell Bioassay for Measurement of Food Iron Bioavailability06:34

The Caco-2 Cell Bioassay for Measurement of Food Iron Bioavailability

Published on: April 28, 2022

5.3K
A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition04:53

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition

Published on: September 20, 2019

11.0K

Related Concept Videos

Pharmacokinetics in Pediatric Patients: Overview and Drug Absorption01:23

Pharmacokinetics in Pediatric Patients: Overview and Drug Absorption

Understanding the physiological differences in the pediatric population is crucial for effective pharmacotherapy. Neonates, infants, and children exhibit significant variations in gastric pH, gastric emptying time, intestinal transit time, and biliary function. These variations profoundly affect oral drug absorption, necessitating a nuanced approach to pediatric dosing.Neonates present with a unique physiological profile, having a gastric pH greater than 4 and faster and more irregular gastric...
106
Bioequivalence: Overview01:16

Bioequivalence: Overview

Pharmaceutical equivalents, by definition, are drug products with the same active ingredient in the same quantities, encapsulated in identical dosage forms, and intended for the same administration routes. These pharmaceutical equivalents are deemed bioequivalent if the bioavailability of the active entity in the drug preparations is similar. Moreover, pharmaceutical equivalents demonstrating bioequivalence are also regarded as therapeutically equivalent. This means that when used as directed,...
1.4K
Bioavailability Study Design: Healthy Subjects Versus Patients01:15

Bioavailability Study Design: Healthy Subjects Versus Patients

Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...
62
Bioavailability Study Design: Absolute Versus Relative Bioavailability01:27

Bioavailability Study Design: Absolute Versus Relative Bioavailability

Bioavailability is a crucial pharmacokinetic parameter that quantifies the proportion of an administered drug that reaches the systemic circulation and is available for therapeutic action. Regulatory agencies mandate the assessment of bioavailability, typically measured as the area under the drug plasma concentration-versus-time curve (AUC), to ensure the efficacy and safety of pharmaceutical products. These evaluations are categorized as absolute and relative bioavailability studies.Absolute...
127
Pharmaceutical Equivalents01:26

Pharmaceutical Equivalents

As defined by regulatory standards, pharmaceutical equivalents require generic drug products to have identical dosage forms and chemically identical active pharmaceutical ingredients (APIs). They must adhere to compendial or applicable standards for potency, content uniformity, disintegration times, and dissolution rates. In the case of modified-release dosage forms, variations in drug content are permissible as long as the delivered amount remains consistent with the innovator drug product.
89
Introduction to Electrolytes01:33

Introduction to Electrolytes

In humans, electrolytes play a vital role in various physiological processes. Balancing electrolyte levels is essential for normal body functions; their imbalance can be life-threatening. The major electrolytes include sodium, potassium, chloride, calcium, phosphate, and bicarbonate. They are primarily involved in physiological processes, such as nerve signal transmission, membrane trafficking, muscle contraction, buffering body fluids, and balancing water levels in the body.
Role of Sodium
One...
14.5K