Iron Supplementation and Side Effects

Iowa State University

Status: Completed

Conditions: Iron Deficiency Anemia; Iron Overload

Treatments: Other: Placebo; Dietary Supplement: Aspiron; Dietary Supplement: Ferrous sulfate

Study type: Interventional

Funder types: Other

Identifiers

NCT04018300

SEAS

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 17 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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17 participants in 3 patient groups, including a placebo group

Ferrous sulfate

Experimental group

Description:

Subjects will take a 65 mg Fe capsule of ferrous sulfate, once daily for 21 consecutive days. The first treatment capsule will be consumed with a semi-purified meal (egg albumin, sugar, vanilla, maltodextrose and corn oil) and will have blood drawn hours 0, 1, 2, 3, 4, 6 and 8 post consumption. Serum will be used to determine non-transerrin bound iron, serum iron and percent saturation. Throughout the treatment period, subjects are informed to consume the capsule with food and report symptoms in an online questionnaire. Following three weeks treatment, participants return for a blood draw and oxidative stress indicators are measured. A three week washout period with placebo treatment takes place between treatment crossover.

Treatment:

Dietary Supplement: Ferrous sulfate

Aspiron

Experimental group

Description:

AspironTM which is an iron-enriched supplement will follow the same guidelines and protocol as ferrous sulfate arm. Equivalent 65 mg Fe per capsule will be administered to participants.

Treatment:

Dietary Supplement: Aspiron

Placebo

Placebo Comparator group

Description:

Participants will follow the same description for the other two experimental treatment groups. Capsules will be given to subjects in opaque formation, therefore will be unable to differentiate the iron supplements.

Treatment:

Other: Placebo