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The efficacy of the Fish/Leaf has been tested in over 15 clinical and laboratory/hospital trials. The original work was carried out by graduate students who formed Lucky Iron Fish Enterprise but since that time, the trials have been carried out by independent research teams from different universities and NGOs from different countries around the world. The majority of these trials are randomized and controlled. References to key publications are provided below.

Studies have been carried out on infants (aged 1-5 years); school-aged children (aged 5-7 years); women of reproductive age (aged 18-55 years); and HIV-positive patients [men and women] (aged 15-35 years).

Regular use of the Fish or Leaf results in an improvement in iron status compared with controls. Most of the clinical trials have studied the iron on hemoglobin, a type of protein in red blood cells that carries oxygen to the body's tissues and transports carbon dioxide from the tissues back to the lungs. Iron is a critically important building block for each molecule of hemoglobin. If a blood test shows that hemoglobin levels are lower than normal, the person is referred to as suffering from clinical anemia. Although there are other causes of anemia, a lack of iron in the diet is the most common cause of anemia; known as iron deficiency anemia.

There are a variety of clinical signs and symptoms of iron deficiency anemia: in adults these can vary from relatively minor problems such as frequent headaches, poor hair and nail quality, pale skin, and difficulty concentrating, but the signs and symptoms can be more severe as the condition progresses. More severe problems include periods of dizziness, fainting and profound fatigue. In the most extreme cases iron deficiency anemia can result in complications in pregnancy and birth and even death. Children suffer from many of the same symptoms as iron deficient adults but critically iron deficiency can lead to physical stunting, delayed or permanent cognitive development and failure to thrive. As a pregnant mother is the only source of iron for her baby, a mother suffering from iron deficiency anemia will give birth to an iron deficient child.

Reversing iron deficiency anemia improves the health status of adults but the physical and cognitive impairment in children is permanent.

Iron is absorbed from the food and drink that we consume. When there is not enough iron in the diet then the body responds first by using up iron stores until it runs out of iron to make hemoglobin. Using the Lucky Iron Fish/Lucky Shakti Leaf on a regular basis boosts the amount of this vital mineral in the diet and helps reverse the problems caused by iron deficiency anemia. Preparing food or drink according to instruction releases a small amount of iron that fortifies the diet. The amount of iron released from the Fish/Leaf is small so there are no negative side-effects reported and the Fish/Leaf are compatible for people living with HIV and malaria. Because the level of iron released from Fish/Leaf is similar to the levels seen in fortification of food staples like flour or rice, the product is safe to use alone or in combination with other iron-enriching products.

The Fish or Leaf only reduces anemia if users are suffering from iron deficiency and iron deficiency anemia. This is why one trial in the Preah Vihear Province of Cambodia did not work because it transpired that the vast majority of the participants were not suffering from iron deficiency anemia, but anemia caused by a genetic condition.

It is important to remember that the Fish/Leaf is only helpful if it is used according to the manufacturer’s instructions.