Iron Supplementation and Side Effects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-08

Study Completion Date

2018-04-18

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Iron Deficiency Anemia Iron Overload

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Three armed, cross-over, double blinded design. Fifteen subjects will be randomized to treatment FeSO4, ASP or placebo for two week per treatment. Following each treatment, will be a two week washout period whereby subjects will not consume a supplement. Baseline and final blood draws of each treatment will be collected, in addition to serum collection at 0h, 1h, 2h, 3h, 4h following one dose to determine NTBI concentration curve.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Treatments will be randomized to A or B. Investigators will be blinded to the corresponding treatment, in addition to the subjects being randomized to follow the sequence of supplements as ACB or BCA.

Study Groups

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Ferrous sulfate

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.

Group Type EXPERIMENTAL

Ferrous sulfate

Intervention Type DIETARY_SUPPLEMENT

65 mg Fe as ferrous sulfate

Aspiron

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.

Group Type EXPERIMENTAL

Aspiron

Intervention Type DIETARY_SUPPLEMENT

65 mg Fe as iron-enriched koji culture, called AspironTM

Placebo

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Contains maltodextrin.

Interventions

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Ferrous sulfate

65 mg Fe as ferrous sulfate

Intervention Type DIETARY_SUPPLEMENT

Aspiron

65 mg Fe as iron-enriched koji culture, called AspironTM

Intervention Type DIETARY_SUPPLEMENT

Placebo

Contains maltodextrin.

Intervention Type OTHER

Other Intervention Names

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Aspergillus oryzae Starch pill

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes