Iron Supplementation and Side Effects
Iron Deficiency Anemia, Iron Overload
About this trial
This is an interventional basic science trial for Iron Deficiency Anemia focused on measuring ferrous sulfate, non-transferrin bound iron, oral iron supplement, oral iron supplement side effects
Eligibility Criteria
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
Sites / Locations
- Iowa State University
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
Ferrous sulfate
Aspiron
Placebo
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.
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.
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.