Iron Supplementation and Side Effects
- Conditions
- Iron OverloadIron Deficiency Anemia
- Registration Number
- NCT04018300
- Lead Sponsor
- Iowa State University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 17
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Area under the serum iron curve over 8 hours 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 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 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 Outcome Measures
Name Time Method Change in protein carbonyls Baseline and 21 days Change from baseline to 21 days of protein carbonyls (nmol/mL) oxidative stress after taking either Ultimine, FeSO4, or placebo for 3 consecutive weeks.
Change in hematocrit Baseline and 21 days Change from baseline to 21 days of iron status through hematocrit (%) production after taking either Ultimine, FeSO4, or placebo for 3 consecutive weeks.
Change in soluble transferrin receptor (sTFR) Baseline and 21 days Change from baseline to 21 days of iron status through sTFR (ng/mL) production after taking either Ultimine, FeSO4, or placebo for 3 consecutive weeks.
Change in total iron binding capacity (TIBC) Baseline and 21 days Change from baseline to 21 days of iron status through TIBC (µg/dL) production after taking either Ultimine, FeSO4, or placebo for 3 consecutive weeks.
Change in creatinine Baseline and 21 days Change from baseline to 21 days of kidney function through creatinine (mg/dL) production after taking either Ultimine, FeSO4, or placebo for 3 consecutive weeks.
Change in aspartate aminotransferase (AST) Baseline and 21 days Change from baseline to 21 days of kidney function through AST (U/L) production after taking either Ultimine, FeSO4, or placebo for 3 consecutive weeks.
Change in hemoglobin Baseline and 21 days Change from baseline to 21 days of iron status through hemoglobin (g/dL) production after taking either Ultimine, FeSO4, or placebo for 3 consecutive weeks.
Change in glomerular filtration rate (eGFR) Baseline and 21 days Change from baseline to 21 days of kidney function through eGFR (mL/min/1.73m2) production after taking either Ultimine, FeSO4, or placebo for 3 consecutive weeks.
Change in thiobarbituric acid reactive substances (TBARS) Baseline and 21 days Change from baseline to 21 days of TBARS (µM) oxidative stress after taking either Ultimine, FeSO4, or placebo for 3 consecutive weeks.
Change in hepcidin Baseline and 21 days Change from baseline to 21 days of inflammatory status via hepcidin (ng/mL) after taking either Ultimine, FeSO4, or placebo for 3 consecutive weeks.
Change in C-reactive protein Baseline and 21 days Change from baseline to 21 days of inflammatory status via C-reactive protein (mg/L) after taking either Ultimine, FeSO4, or placebo for 3 consecutive weeks.
Change in serum ferritin Baseline and 21 days Change from baseline to 21 days of iron status through serum ferritin (µg/L) after taking either Ultimine, FeSO4, or placebo for 3 consecutive weeks.
Change in blood urea nitrogen (BUN) Baseline and 21 days Change from baseline to 21 days of kidney function through BUN (mg/dL) production after taking either Ultimine, FeSO4, or placebo for 3 consecutive weeks.
Change in alanine aminotransferase (ALT) Baseline and 21 days Change from baseline to 21 days of kidney function through ALT (U/L) production after taking either Ultimine, FeSO4, or placebo for 3 consecutive weeks.
Gastrointestinal symptoms 21 days Symptoms questionnaire was distributed 3 days/week over 3 weeks/treatment. Total survey per supplemental treatment included 9 surveys. Participants described how the supplement contributed to gastrointestinal distress, such as, constipation, diarrhea, fatigue, abdominal discomfort, nausea, headaches, and heartburn.
Trial Locations
- Locations (1)
Iowa State University
🇺🇸Ames, Iowa, United States
Iowa State University🇺🇸Ames, Iowa, United States