Iron Deficiency Anaemia is a condition whereby iron store depletion is associated with low blood volume in the body, i.e. a haemoglobin (Hb) concentration below an established cut-off value, consequently impairing the capacity of the blood to transport oxygen around the body. According to the World Health Organisation (WHO) about 30% of the world’s population suffers from anaemia.

Oral iron supplements are considered as safe, cheap, and effective in restoring iron balance. Side effects associated with iron supplementation are mostly gastrointestinal side effects including abdominal discomfort, nausea, vomiting, constipation, and dark colored stools.

With more than five decades of international use, the efficacy and the safety of Tot'héma® in the curative and prophylactic treatment of IDA has been well established. Several clinical trials conducted in different populations have supported the efficacy of Tot'héma® in IDA, showing normalization of biological parameters such as Hb and ferritin blood levels after treatment with Tot'héma®.

Iron supplementation has long been proven to be effective for the treatment of IDA and iron treatment is recommended by many international organizations (WHO) and national learned societies (UK, US, India).

However, only few studies have demonstrated an increase in the Hb level and in biological parameters associated with IDA at early stages of treatment by iron supplementation.  A significant increase in Hb level was already observed after 1 week of iron supplementation in a study conducted on women with severe postpartum anaemia. In a study conducted on chronic kidney disease patients with IDA, the increase in Hb level was significant after 3 weeks of iron treatment. An analysis of pooled data from 5 randomized trials identified patients with an increase of Hb ≥ 1 g/dL at 14 days of treatment as responders to iron supplementation.

The purpose of this study is to obtain data on the biological parameters associated with IDA at the very early stages of treatment (3rd, 5th, 7th days) to assess the Onset-of-Action of an Iron gluconate liquid formulation (Tot'héma®). The efficacy and the safety of Tot'héma®, administered according to the summary of product characteristics (SmPC) recommendations, will also be evaluated regularly during the scheduled 12 weeks of treatment for the study.

The IP is registered in kenya. Registration number in Kenya is n°H2009/19801/578

Iron Deficiency Anaemia is a condition whereby iron store depletion is associated with low blood volume in the body, i.e. a haemoglobin (Hb) concentration below an established cut-off value, consequently impairing the capacity of the blood to transport oxygen around the body. According to the World Health Organisation (WHO) about 30% of the world’s population suffers from anaemia.

Oral iron supplements are considered as safe, cheap, and effective in restoring iron balance. Side effects associated with iron supplementation are mostly gastrointestinal side effects including abdominal discomfort, nausea, vomiting, constipation, and dark colored stools.

With more than five decades of international use, the efficacy and the safety of Tot'héma® in the curative and prophylactic treatment of IDA has been well established. Several clinical trials conducted in different populations have supported the efficacy of Tot'héma® in IDA, showing normalization of biological parameters such as Hb and ferritin blood levels after treatment with Tot'héma®.

Iron supplementation has long been proven to be effective for the treatment of IDA and iron treatment is recommended by many international organizations (WHO) and national learned societies (UK, US, India).

However, only few studies have demonstrated an increase in the Hb level and in biological parameters associated with IDA at early stages of treatment by iron supplementation.  A significant increase in Hb level was already observed after 1 week of iron supplementation in a study conducted on women with severe postpartum anaemia. In a study conducted on chronic kidney disease patients with IDA, the increase in Hb level was significant after 3 weeks of iron treatment. An analysis of pooled data from 5 randomized trials identified patients with an increase of Hb ≥ 1 g/dL at 14 days of treatment as responders to iron supplementation.

The purpose of this study is to obtain data on the biological parameters associated with IDA at the very early stages of treatment (3rd, 5th, 7th days) to assess the Onset-of-Action of an Iron gluconate liquid formulation (Tot'héma®). The efficacy and the safety of Tot'héma®, administered according to the summary of product characteristics (SmPC) recommendations, will also be evaluated regularly during the scheduled 12 weeks of treatment for the study.

Primary objective

To assess, in patients with moderate IDA, the Onset-of-Action of a daily treatment with Tot'héma®. The onset of action is defined as the time required for a mean increase of at least 0.5 g/dL from baseline in the haemoglobin level.

Secondary objectives

1. Assessment, in patients with moderate IDA, of the Onset-of-Action of a daily treatment with Tot'héma® separately within each of the 2 geographic zones. The onset of action is defined as the time required for a mean increase of at least 0.5 g/dL from baseline in haemoglobin level.
2. Assessment, in patients with moderate IDA, of the Onset-of-Action of a daily treatment with Tot'héma®, defined as the time required for a mean increase of at least 2 g/dL from baseline in the haemoglobin level.
3. Assessment of the proportion of patients with moderate IDA treated with Tot'héma® achieving different levels of improvement and, ultimately, a normalization of haemoglobin level over time.
4. Assessment of the time course of the increase and, ultimately, the normalization of haemoglobin level in patients with moderate IDA treated with Tot'héma®.
5. Assessment of the evolution of biological markers of anaemia in patients with moderate IDA treated with Tot’héma®.
6. Assessment of the evolution of the mean level of C-Reactive Protein (CRP) in patients with moderate IDA treated with Tot'héma®.
7. Assessment of the evolution of fatigue in patients with moderate IDA treated with Tot'héma®.
8. Assessment of the evolution of quality of life of patients with moderate IDA treated with Tot'héma®.
9. Performance of conjunctival pallor for detecting anaemia and its evolution during treatment.
10. Assessment of patient compliance with treatment.
11. Assessment of treatment safety.
12. Assessment of the overall level of investigators satisfaction with the treatment.