Clinical trial NCT04018300: Iron Supplementation and Side Effects
Official title: Assessment of Gastrointestinal Symptoms and Other Side Effects After Three Week Oral Ferrous Sulfate and Iron-enriched Aspergillus Oryzae Supplementation in Young Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron Deficiency Anemia
Iron Overload
Keywords: ferrous sulfate
non-transferrin bound iron
oral iron supplement
oral iron supplement side effects
Lead sponsor: Iowa State University
Sponsor class: OTHER
First posted: 2019-07-12
Enrollment: 17
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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 purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed 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.

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

Primary outcomes:
measure: Area under the serum iron curve over 8 hours
timeFrame: 0,1,2,3,4,6 and 8 hours
measure: Area under the NTBI curve over 8 hours
timeFrame: 0,1,2,3,4,6 and 8 hours
measure: Area under the percent transferrin saturation curve over 8 hours
timeFrame: 0,1,2,3,4,6 and 8 hours
Secondary outcomes:
measure: Change in protein carbonyls
timeFrame: Baseline and 21 days
measure: Change in thiobarbituric acid reactive substances (TBARS)
timeFrame: Baseline and 21 days
measure: Change in hepcidin
timeFrame: Baseline and 21 days
measure: Change in C-reactive protein
timeFrame: Baseline and 21 days
measure: Change in serum ferritin
timeFrame: Baseline and 21 days
measure: Change in hemoglobin
timeFrame: Baseline and 21 days
measure: Change in hematocrit
timeFrame: Baseline and 21 days
measure: Change in soluble transferrin receptor (sTFR)
timeFrame: Baseline and 21 days
measure: Change in total iron binding capacity (TIBC)
timeFrame: Baseline and 21 days
measure: Change in glomerular filtration rate (eGFR)
timeFrame: Baseline and 21 days
measure: Change in creatinine
timeFrame: Baseline and 21 days
measure: Change in blood urea nitrogen (BUN)
timeFrame: Baseline and 21 days
measure: Change in aspartate aminotransferase (AST)
timeFrame: Baseline and 21 days
measure: Change in alanine aminotransferase (ALT)
timeFrame: Baseline and 21 days
measure: Gastrointestinal symptoms
timeFrame: 21 days
Other outcomes:
Locations:
city: Ames
country: United States
facility: Iowa State University
state: Iowa
Study officials:
affiliation: Iowa State University
name: Manju B Reddy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bries AE, Wang C, Agbemafle I, Wels B, Reddy MB. Assessment of Acute Serum Iron, Non-Transferrin-Bound Iron, and Gastrointestinal Symptoms with 3-Week Consumption of Iron-Enriched Aspergillus oryzae Compared with Ferrous Sulfate. Curr Dev Nutr. 2019 Nov 7;3(12):nzz127. doi: 10.1093/cdn/nzz127. eCollection 2019 Dec.