SunActive studies impact of emulsified microsomal iron in pregnancy

By Matt Chittock

- Last updated on GMT

© dragana991 / Getty Images
© dragana991 / Getty Images

Related tags maternal health Iron anaemia

In a new Indian study, researchers investigated the safety and effectiveness of 30 mg SunActive Fe emulsified microsomal ferric pyrophosphate (EMFP) tablets for treating iron deficiency anemia (IDA) in second-trimester pregnant women.

This is an important area of study, since iron deficiency is a significant global health problem, especially for pregnant women. New approaches are needed because traditional iron treatments can come with many negative side effects.

After the intervention, the researchers found that subjects’ serum ferritin levels [which are directly related to the amount of iron in the body] increased 6.61-fold. Serum iron also increased by 46.9%. Adverse symptoms like irritability and heartburn were reduced while subjects reported less overall fatigue.

“SunActive Fe supplementation can serve as a choice of therapy for IDA in pregnancy, both therapeutically and prophylactically,” the researchers wrote.

Towards more tolerable treatments

Anemia is marked by iron deficiency, reduced hemoglobin (Hb) levels and low red blood cell (RBC) count​. It presents a serious global health threat, especially for pregnant women because undetected and untreated IDA adversely affects fetal development and maternal health, with symptoms including pallor, fatigue and dizziness.

Anemia is also connected to complications like premature delivery, low birth weight (LBW), preeclampsia, postpartum maternal sepsis, hemorrhage and maternal and child mortality​.

IDA treatment includes oral and intravenous iron replacement. Oral iron salts like ferrous fumarate, gluconate and sulfate are widely used. However, long-term treatment is limited by changes in taste and gastrointestinal symptoms. A systematic review showed gastrointestinal side effects are the greatest challenge​.

Researchers have become increasingly interested in alternative compounds with higher bioavailability which also have superior gastrointestinal tolerability. These include chelated ferrous forms or oral iron nanoparticles​.

“It is crucial to identify the most suitable iron form and determine the optimal treatment duration to effectively replenish iron stores, restore normal Hb levels and minimize side effects in a more assured and appropriate manner,” the researchers noted.

An open-level clinical investigation

The open-label clinical evaluated 27 subjects with an average age was 27.37 years. The sample size was based on a biostatistical power analysis looking at prior published results with SunActive​. Data was collected from December 2022 to June 2023.

After checking for possible allergies to the product, from the first visit patients took a 30 mg EMFP tablet once a day before lunch for 90 days. Adherence was assessed throughout the study.

Following study completion, fetal weight and gestational age were recorded. A t-test was used to compare efficacy parameters with baseline and results at 30, 60 and 90 days.

Results showed subjects’ hemoglobin levels increased significantly (up 2.86 g/dl) within 30 days of treatment and continued to remain higher than baseline throughout the study. Serum ferritin levels increased 6.61-fold, maintaining consistently elevated levels. Serum iron increased by 46.9%. Treatment compliance was high at 99.5%.

Symptoms such as nausea, breathlessness, dizziness, irritability and heartburn decreased, leading to improved quality of life. Subjects reported a reduction in overall fatigue. Babies born during the study had healthy birth weights, and the women experienced uncomplicated deliveries.

“These findings suggest that EMFP could be a valuable therapeutic option for managing iron deficiency anemia in pregnant women, promoting better maternal and fetal outcomes,” the study concluded.

As study limitations, the researchers identified the small sample size and suggested future research to strengthen the evidence.

Source: Cureus
doi: 10.7759/cureus.57108
“Efficacy and Safety of Microsomal Ferric Pyrophosphate Supplement for Iron Deficiency Anemia in Pregnancy.”
Authors: Ankita Srivastav, et al.

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