Safe and Effective Delivery of Supplemental Iron to Healthy Volunteers

NACompletedINTERVENTIONAL
Enrollment

226

Participants

Timeline

Start Date

May 17, 2017

Primary Completion Date

December 30, 2021

Study Completion Date

July 30, 2022

Conditions
Iron
Interventions
DIETARY_SUPPLEMENT

Ferrous sulfate

Standard-of-care therapy for iron deficiency anaemia

DIETARY_SUPPLEMENT

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.

DIETARY_SUPPLEMENT

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.

OTHER

Placebo

Cornstarch

Trial Locations (2)

02111

Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, Boston

02115

Boston Children's Hospital, Boston

All Listed Sponsors
collaborator

Bill and Melinda Gates Foundation

OTHER

lead

Tufts University

OTHER

NCT03212677 - Safe and Effective Delivery of Supplemental Iron to Healthy Volunteers | Biotech Hunter | Biotech Hunter