Evaluation of efficacy and safety of Micellar Iron in the treatment of Iron Deficiency Anaemia patients: A prospective, randomised, double-blind, single centre, placebo-controlled, interventional study

Anaemia can be caused by iron deficiency, folate deficiency, vitamin B12 deficiency, and other causes. The term iron deficiency anaemia (IDA) means anaemia that is due to iron deficiency. Iron deficiency anaemia is characterized by the production of small red blood cells. The most common cause of anaemia include nutritional deficiencies, particularly iron deficiency. Iron deficiency anaemia is affiliated with weakness, fatigue, difficulty concentrating, and reduced physical activity, which direct to deterioration in quality of life and productivity of work. Both in developed and developing countries iron deficiency anaemia is a public health problem affecting about a third of the world’s population. It is noted to appear at all stages of life; children aged 0 to 5 years, women of childbearing age, and pregnant women are particularly at risk. Harmonizing to the World Health Organization report, iron deficiency is the main cause for all the 50% of cases of anaemia. In India the prevalence of any type of anaemia is very high (>95%) among young, adults, and women in gestation. Global Burden of Disease Study 2016, which performed a methodical analysis concluded that, iron-deficiency anaemia was the fourth leading to cause disability in life-style, mostly in women.

Maximum of the adults have at least 3000mg (45mg/Kg) elemental iron in their bodies. Females commonly have decreased levels than males by reason of the iron loss during menses, pregnancies, and lactation. 20mg of iron is recycled daily to manage sufficient supplies of iron for haem synthesis. Accurate diagnosis can play a crucial role in management of IDA. According to WHO, IDA is defined as a level of haemoglobin (Hb) below 13.0 g/dL in male adults, below 12.0 g/dL in female adults who are not pregnant, and below 11.0 g/dL in pregnant women.

Despite the large variety of pharmaceutical products available to treat the iron deficiency anaemia, there are few studies concerning the impact of preventive measurements on nutritional status of iron. Moreover, some of the studies have compared the relative effectiveness of different iron compounds. Among all iron compounds, ferrous sulfate is the mostly recommended iron compound in supplementation because of its low-cost effectiveness. However, it also increases the frequency of gastrointestinal tract adverse effects e.g. nausea, constipation, diarrhea, flatulence, and black stained stools. Besides, bioavailable ferrous sulfate may be decreased by many foods in the gastrointestinal tract which interfere with its absorption leading to variability in the haemoglobin correction during the treatment. Micellar Iron (Ferrous bis-glycinate) has been proposed as an alternative to ferrous sulfate because of its increased bioavailability. Hence, the present study is intended to determine the impact of Micellar Iron on treatment of iron deficiency anaemia.