Assessment of Gastrointestinal Symptoms and Other Side Effects After Three Week Oral Ferrous Sulfate and Iron-enriched Aspergillus Oryzae Supplementation in Young Female Subjects
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Iron Deficiency Anemia
- Sponsor
- Iowa State University
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- Area under the serum iron curve over 8 hours
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Dr. Manju B. Reddy
Professor
Iowa State University
Eligibility Criteria
Inclusion Criteria
- •Age 18-40
- •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
- •Anemic (\< 120 g/L)
- •Ferritin \> 40 ug/L
Outcomes
Primary Outcomes
Area under the serum iron curve over 8 hours
Time Frame: 0,1,2,3,4,6 and 8 hours
Serum iron concentrations (µM) measured over 8 hours following consumption of either Ultimine, FeSO4, or placebo capsules at baseline (0h).
Area under the NTBI curve over 8 hours
Time Frame: 0,1,2,3,4,6 and 8 hours
NTBI (µM) concentrations measured over 8 hours following consumption of either Ultimine, FeSO4, or placebo capsules at baseline (0h).
Area under the percent transferrin saturation curve over 8 hours
Time Frame: 0,1,2,3,4,6 and 8 hours
Percent transferrin (%) saturation concentrations measured over 8 hours following consumption of either Ultimine, FeSO4, or placebo capsules at baseline (0h).
Secondary Outcomes
- Change in protein carbonyls(Baseline and 21 days)
- Change in hematocrit(Baseline and 21 days)
- Change in soluble transferrin receptor (sTFR)(Baseline and 21 days)
- Change in total iron binding capacity (TIBC)(Baseline and 21 days)
- Change in creatinine(Baseline and 21 days)
- Change in aspartate aminotransferase (AST)(Baseline and 21 days)
- Change in hemoglobin(Baseline and 21 days)
- Change in glomerular filtration rate (eGFR)(Baseline and 21 days)
- Change in thiobarbituric acid reactive substances (TBARS)(Baseline and 21 days)
- Change in hepcidin(Baseline and 21 days)
- Change in C-reactive protein(Baseline and 21 days)
- Change in serum ferritin(Baseline and 21 days)
- Change in blood urea nitrogen (BUN)(Baseline and 21 days)
- Change in alanine aminotransferase (ALT)(Baseline and 21 days)
- Gastrointestinal symptoms(21 days)