FAST Research Study - Assessments of the efficacy, the Onset-of-Action and the Safety of Tot'héma® in adults with moderate Iron deficiency anemia
At Nyanza Reproductive Health Society (NRHS), we’re committed to improving the health and well-being of communities in Kenya. We’re currently involved in an exciting clinical trial, FAST, which evaluates the effectiveness and safety of Tot'héma®, an oral solution used to treat moderate iron deficiency anemia (IDA) in adults. This trial, now at the data analysis stage, has the potential to change how we approach anemia treatment in the region and beyond.
What is Iron Deficiency Anemia (IDA)?
Iron deficiency anemia is a condition where the body lacks enough iron, leading to low hemoglobin (Hb) levels. This affects the blood’s ability to carry oxygen to vital organs, causing fatigue, weakness, and other health issues. IDA is a major health concern globally, affecting approximately 30% of the world's population, with many living in low-income areas, including parts of Kenya.
Although iron supplements are commonly used to treat IDA, they often come with side effects like stomach upset and constipation, which can make it hard for people to stay on treatment.
What is Tot'héma® and Why is It Important?
Tot'héma® is an iron gluconate oral solution that has been used internationally for years to treat IDA. This study, sponsored by Laboratoire INNOTECH INTERNATIONAL and supported by NRHS, aims to provide more detailed information on how quickly Tot'héma® works and how safe it is, especially in patients from different regions like Kenya and Europe.
The goal is to better understand the onset of action—how soon after starting treatment we can see improvements in hemoglobin levels and fatigue. This data is crucial to help us provide more effective and timely care for those suffering from moderate IDA.
Study Goals and What We’re Learning
Now that we are in the data analysis stage, we are reviewing results to understand how Tot'héma® has worked for the patients involved. The key objectives of this study include:
- Primary Goal: We want to know how soon patients’ hemoglobin levels increase by at least 0.5 g/dL after starting treatment. This will help us understand the onset of action of the drug.
- Secondary Goals:
- Monitor how quickly hemoglobin levels rise to greater thresholds, like 1 g/dL or 2 g/dL.
- Track when hemoglobin levels return to normal (e.g., 12 g/dL for women, 13 g/dL for men).
- Evaluate the impact of treatment on fatigue and quality of life.
- Assess safety and any side effects related to the medication.
While we’re still analyzing the data, these goals are helping us understand how Tot'héma® works across different geographic regions and how it can improve the lives of those with iron deficiency anemia.
Why This Matters
Iron deficiency anemia is a widespread issue that often goes untreated or poorly managed, especially in resource-limited settings. This study is a crucial step in improving treatment options for individuals in Kenya and globally. By assessing Tot'héma®, we aim to provide more effective, safe, and timely solutions for people suffering from IDA.
The Impact of the Study So Far
Through this study, we’ve gathered data from multiple centers across Europe and Kenya, involving 121 participants. The results, once fully analyzed, will help us better understand how quickly iron supplementation can improve hemoglobin levels and fatigue—key symptoms of anemia. As we move forward, the insights from this study will not only help healthcare providers make better treatment decisions but also provide a foundation for future research and treatment strategies.
How Can You Help?
This study wouldn’t be possible without the support of our partners and donors. If you’re interested in making a difference and supporting the fight against iron deficiency anemia, we encourage you to get in touch with us. Together, we can help provide more effective healthcare solutions to those who need it the most.
Stay tuned for more updates as we finalize the analysis and share the study’s findings. By joining us in this journey, you’re part of a global effort to combat anemia and improve health outcomes in Kenya and beyond.