First clinical studies in humans - a scientific approach

A scientific approach has been used in all our endeavors to find a solution to combat iron deficiency. All raw materials used have been analyzed according to approved scientific methods and accredited government institutions. The clinical studies performed and approved according to strict scientific and ethical guidelines and known procedures. The raw material used is harvested and handled in accordance with rules and regulations that ensure sustainable utilization of natural resources.

First clinical studies in humans

In 2019, Hemjern AS sponsored the first clinical study on humans to measure the absorption rate of heme iron in blood serum. The pilot study was conducted at Haukeland University Hospital, Bergen, in accordance with scientific and ethical norms, procedures and guidelines. 39 participants were enrolled in the study, 11 without severe iron deficiency. Definition of iron deficiency at S-Fe <20μg / l.

Only 100% natural raw materials from deep-diving marine mammals in the North Atlantic area were used. Two different methods of processing the raw materials were tested.

The purpose of the pilot study was to test whether heme iron would be absorbed in physiologically relevant amounts. Based on the positive results from the absorption study, a new clinical study to document the long-term effect on iron deficiency has been initiated.

Tabel 1. Average increase in S-Fe after intake of natural heme iron, from start, 2 and 4 hours respetively.

The results of the study in humans confirmed previous studies in animals, the absorption rate of 30-35% for all the raw materials used was achieved. Home iron was, as expected, easily absorbed into the blood serum without registered side effects.

The study was designed with blood samples taken at 0-hour, followed by intake of heme iron supplements, then blood samples were taken after 2 hours and 4 hours. According to 1, 2, 3 in the table below.

Table increase in S-Fe in an adolescent

Increase in S-Fe in an adolescent from zero, 2 and 4 hours respectively

In a particular case, S-Fe increased by 100% from the intake hour 0 to the last sample after 4 hours. In this case, S-Fe was low, which is supported by scientific findings that the absorption rate increases with the degree of iron deficiency. After one month of regular intake of 1 mg heme iron, s-Fe returned to a normal level and blood status was regained

The results of the absorption experiment are remarkable in light of the fact that only a very low dose of 2 to 4 mg of heme iron was used. .

 Scientific studies of the long-term effect

The preliminary results obtained confirm the effect of an absorption rate of around 30% for all the raw materials used. No side effects have been reported. The results lay the groundwork for a long-term study to uncover the effect of a heme iron supplement to combat iron deficiency and iron deficiency anemia.

Hemjern As is in contact with several research institutions in order to conduct a 4-month clinical study for this purpose.