Clinical trials: Fortification
Micronutrient Deficiencies
Effect of Sprinkles With and w/o Fe on Zn Absorption in Kenyan Toddlers
The investigators propose to study the effects of increased iron intake by home fortification of complementary foods on the gastrointestinal microbial development, inflammatory responses, and zinc (Zn) absorption.
- Trial name
- NCT02101723
- Testing
- MNP + Zn/Fe, MNP + Zn
- Where
- 2 sites in United States, Kenya
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Denver
Neurodevelopmental Disorders, Lactation
Iron Supplement Effect on Child Development
Objective: To evaluate the effect of Iron supplement with two different amounts (one in the higher limit and another in the lower limit of the suggested amount) according to the presence of mutations in the HFE gene in the…
- Trial name
- NCT02690675
- Testing
- Iron fortified formula milk
- Volunteers
- 133 people, healthy volunteers welcome
- Sponsor
- University Rovira i Virgili
Preterm, Very Low Birth Weight Infant
Weight Gain in Extremely Premature Infant With Targeted Versus Adjusted Fortification
Investigation about the effect on weight gain in extremely low birth weight preterm with individualized fortification, according to human milk analysis versus fortification adjusted according to urea serum concentration.
- Conditions
- Preterm, Very Low Birth Weight Infant, Feeding, Breast, Food, Fortified
- Trial name
- FORTIN (NCT04982133)
- Testing
- Protein supplementation based on plasma urea concentration every other week or human milk analysis on experiment
- Where
- Spain
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Hospital Universitario La Paz
Growth, Body Composition
Effect of Target Fortified Human Milk on the Growth Quality of Very Preterm Infants (TargetFort)
It is reported that the standard method for fortification of human milk (HM) overestimates the energy and protein densities of HM (Macedo MHNP 2018), thus originating infant undernutrition (Macedo AJP 2018).
- Conditions
- Growth, Body Composition, Prematurity, Breast Milk Collection
- Trial name
- TargetFort (NCT04400396)
- Testing
- standard HM fortification, target HM fortification
- Where
- Portugal
- Volunteers
- 80 people
- Sponsor
- Centro Hospitalar de Lisboa Central
Vitamin D Deficiency
The Effect of Vitamin D on Bone Accretion and Turn-Over in Young Girls
Objectives To evaluate the effect of increased vitamin D intake on vitamin D status, bone mass and bone turnover in young girls aged 12-13.
- Trial name
- NCT00267540
- Testing
- cholecalciferol (D3) (vitamin)
- Where
- Denmark
- Volunteers
- 225 people, healthy volunteers welcome
- Sponsor
- University of Copenhagen
Anemia
Reducing Anemia Through Food Fortification at Scale
Anemia is the most common form of malnutrition, affecting approximately 1.6 billion people world-wide. Most commonly caused by iron deficiency, its adverse effects include increased mortality (especially during childbirth)…
- Trial name
- NCT03573570
- Testing
- Fortified rice kernels
- Where
- India
- Volunteers
- healthy volunteers welcome
- Sponsor
- Stanford University
Vitamin D Biofortification, Vitamin D Fortification
Vitamin D (Bio)Fortified Shopping Baskets to Improve Vitamin D Status
Vitamin D is essential for healthy bones, muscles, and immune function. It comes from food, supplements, and sunlight. There are two main forms; vitamin D2, found mainly in plant foods, and vitamin D3, which comes from animal…
- Conditions
- Vitamin D Biofortification, Vitamin D Fortification, Vitamin D Status
- Trial name
- NCT07349290
- Testing
- Vitamin D (bio)fortified food basket, Control food basket
- Where
- United Kingdom
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- University of Ulster
Zinc Deficiency
Water-based Zinc Efficacy Trial in Beninese Shool Children
The general objective of this study is to determine the effect of the daily consumption of zinc-fortified water provided by the LSF-filter on zinc status and diarrhea rates in school age children from rural areas characterized by…
- Trial name
- NCT01790321
- Testing
- LSF-filtering device
- Where
- Benin
- Volunteers
- 278 people, healthy volunteers welcome
- Sponsor
- Prof. Michael B. Zimmermann
Preterm Birth, Breast Milk Expression
Targeting Human Milk Fortification to Improve Preterm Infant Growth and Brain Development
This study is a randomized trial comparing 2 methods of human milk fortification for preterm infants in the neonatal intensive care unit (NICU).
- Conditions
- Preterm Birth, Breast Milk Expression, Nutrition Disorder, Infant, Brain Development Abnormality
- Trial name
- NCT03977259
- Testing
- Individually targeted fortification
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- Brigham and Women's Hospital
Infant, Very Low Birth Weight
Randomized Study of Human-Milk Based Nutrition Versus Formula in Premature Infants
The purpose of this study is to determine whether very low birth weight infants (less than or equal to 1250g or about 2 3/4 pounds) born prematurely fed a diet of only human milk and human milk-derived nutrition have better…
- Trial name
- NCT00506584
- Testing
- Pasteurized human milk and pasteurized human milk fortifier, Human milk fortifier (bovine-based), pre-term formula, Pre-term/term formula
- Where
- 13 sites in United States, Austria
- Volunteers
- 260 people
- Sponsor
- Prolacta Bioscience
Feeding Tolerance, Growth
Growth and Feeding Tolerance in Premature Infants
The main purpose of the study is to evaluate the effect of early human milk fortification versus delayed fortification on growth and feeding tolerance in premature infants.
- Trial name
- NCT07409038
- Testing
- early initiation of human milk fortification on feeding tolerance
- Where
- Pakistan
- Volunteers
- 96 people
- Sponsor
- Children's Hospital and Institute of Child Health, Multan
Healthy
Effect of Lutein in S-26 Gold On Growth And Safety
Study to determine if the addition of lutein to infant formula supports healthy growth and development in healthy full term infants.
- Trial name
- S-26 Gold L (NCT00913406)
- Testing
- Lutein fortification, Standard formula
- Volunteers
- 232 people, healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Human Milk, Neonate
Targeted Breast Milk Fortification for Very Low Birth Weight Infants in the NICU
This study evaluates the effectiveness of individualized human milk fortification for very low birth weight (<1500 g) babies in the NICU (Neonatal Intensive Care Unit) to optimize their growth.
- Conditions
- Human Milk, Neonate, Breast Milk
- Trial name
- NCT04025021
- Testing
- Targeted Fortification, The Miris Human Milk Analyzer
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- MetroHealth Medical Center
Very Preterm Maturity of Infant, Very Low Birth Weight Infant
Individualized Nutrition to Optimize Preterm Infant Growth and Neurodevelopment
Human milk has several well-established benefits but does not adequately meet the increased nutritional demands of the growing preterm infant, necessitating additional nutrient supplementation in a process known as fortification.
- Trial name
- THRIVE (NCT06266455)
- Testing
- Standardized Fortification, Adjustable Fortification
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Children's National Research Institute
Very Low Birth Weight Infant, Growth Failure
Targeted Fortification of Pasteurized Donor Human Milk
This randomized controlled trial aims to evaluate a modified targeted fortification method of pasteurized donor human milk (PDHM) in very low birth weight infants (VLBWs).
- Conditions
- Very Low Birth Weight Infant, Growth Failure, Donor Breast Milk
- Trial name
- NCT04640805
- Testing
- Protein supplementation, Analysis with Miris Human Milk Analyzer
- Where
- Singapore
- Volunteers
- 61 people
- Sponsor
- KK Women's and Children's Hospital
Healthy
The Effect of Vitamin D Fortification of Bread and Milk in Danish Families
Approximately 200 families corresponding to 800 persons are included in the study. The study investigate the efficacy of vitamin D fortification of bread and milk on vitamin D status in serum.
- Trial name
- VitMaD (NCT01184716)
- Testing
- Vitamin D fortification
- Where
- Denmark
- Volunteers
- 782 people, healthy volunteers welcome
- Sponsor
- Technical University of Denmark
Anemia, Low Iron Stores
Improving Iron Status Through Consumption Of Iron Fortified Cowpea: An Intervention Study
Rationale: Iron deficiency and zinc deficiency, are of public health significance in sub-Saharan Africa. An estimated 50% of children (5-14 years) in developing countries suffer from anaemia, half of which is estimated iron…
- Trial name
- NCT01208363
- Testing
- Cowpea fortified with NaFeEDTA, in form of Toubani.
- Where
- Ghana
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Wageningen University
Premature Infant
Effect of Increased Enteral Protein on Body Composition of Preterm Infants
The study hypothesis is that, in human milk-fed extremely preterm infants, higher protein intake compared to usual protein intake reduces percent body fat (%BF) at 3 months of age.
- Trial name
- NCT03586102
- Testing
- High protein supplementation, Standard protein supplementation
- Where
- United States
- Volunteers
- 56 people
- Sponsor
- University of Alabama at Birmingham
Anemia, Iron Deficiency
Effectiveness of Iron-Fortified Milk on Iron Status and Anemia in Young Children in Mexico
Iron deficiency and anemia in infants and young children impair neurodevelopment. Efficacious interventions for reducing the prevalences of iron deficiency and anemia, under controlled conditions, are available.
- Conditions
- Anemia, Iron Deficiency, Stunting
- Trial name
- NCT00508131
- Testing
- Whole Cows Milk
- Where
- Mexico
- Volunteers
- 798 people, healthy volunteers welcome
- Sponsor
- Instituto Nacional de Salud Publica, Mexico
Breast Milk, Premature Infant
Individualized Fortification of Breast Milk
Objectives: To compare the effects of two different methods of individualized protein fortification of breast milk on the early growth of VLBW preterm infants.
- Trial name
- NCT03324126
- Volunteers
- 32 people
- Sponsor
- Ozgul Bulut