Iron Supplementation and Side Effects

Assessment of Gastrointestinal Symptoms and Other Side Effects After Three Week Oral Ferrous Sulfate and Iron-enriched Aspergillus Oryzae Supplementation in Young Female Subjects

The objective of this study is to examine patient-reported gastrointestinal side effects, as well as iron status indicators, inflammatory markers and oxidative stress following administration of ferrous sulfate and iron-enriched Aspergillus oryzae supplementation.

Iron deficiency anemia (IDA) afflicts more than 2 billion people globally, making it the most prevalent nutrient disorder, today. Inadequate dietary intake of iron results in consequences like cognitive decline, fatigue, abnormal growth and adverse pregnancy outcomes. These ramifications have associated burdens on economical progression due to decreased market productivity. Inorganic iron supplements like ferrous sulfate (FeSO4) are most commonly used to treat IDA, however known associated side effects occur, decreasing compliancy in individuals. Moreover, inorganic iron salts present a large bolus of iron to the intestinal lumen, resulting in non-transferrin bound iron which leads to systemic inflammation and further exacerbation of chronic diseases. Organic iron compounds have strong potential to be utilized for supplementation, however only under circumstances in which contain high absorbance. Seventeen subjects were randomized in a three-armed, double-blinded crossover design to examine the differences among three treatments (FeSO4, ASP-s and placebo). Outcomes will be to assess acute inflammatory proteins, oxidative stress, iron status indicators, non-transferrin bound iron and gastrointestinal-related side effects.

Inclusion Criteria:

• Age 18-40
• Female
• BMI < 30 kg/m2
• Nonsmoker
• Non pregnant
• Non lactating
• No food allergies to wheat or dairy
• No history of gastrointestinal diseases/disorders
• Willing to discontinue use of vitamin/mineral supplements
• No medications that interfere with iron absorption
• No blood or plasma donations during study period

Exclusion Criteria:

• History of gastrointestinal diseases or disorders
• Donating blood or plasma two weeks prior to study period
• On medications interfering with iron absorption
• Food allergies to wheat or dairy
• Pregnant or lactating
• Smoker
• Anemic (< 120 g/L)
• Ferritin > 40 ug/L