226
Participants
Start Date
May 17, 2017
Primary Completion Date
December 30, 2021
Study Completion Date
July 30, 2022
Ferrous sulfate
Standard-of-care therapy for iron deficiency anaemia
IHAT
IHAT is a nanoparticle composed of three General Regarded As Safe (GRAS) substances, iron hydroxide, tartaric acid and adipic acid. The particle itself resembles the normal metabolite ferritin, which is a larger polyatomic particle. Like ferritin, IHAT can be absorbed by endocytosis, but dissociates within the enterocyte and is subsequently metabolized as ferrous iron.
Aspiron
Aspiron is a product of the natural fermentation of Koji (Aspergillus oryzae) in the presence of ferrous sulfate. The iron-rich koji biomass is heated, harvested and dried which results in the inactivation of Koji powder that contains 8-10% iron. Koji (A. oryzae) is widely used for making such foods as soy sauce, tempeh, miso, and for producing food-grade α-amylase, and is considered safe by Joint Food and Agriculture Organization of the United Nations (FAO)/WHO Committee on Food Additives and has been accepted as a GRAS constituent of food.
Placebo
Cornstarch
Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, Boston
Boston Children's Hospital, Boston
Bill and Melinda Gates Foundation
OTHER
Tufts University
OTHER