Iron Deficiency Anemia, Iron Overload
Conditions
Keywords
ferrous sulfate, non-transferrin bound iron, oral iron supplement, oral iron supplement side effects
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.
Interventions
DIETARY_SUPPLEMENTFerrous sulfate
65 mg Fe as ferrous sulfate
DIETARY_SUPPLEMENTAspiron
65 mg Fe as iron-enriched koji culture, called AspironTM
OTHERPlacebo
Contains maltodextrin.
Sponsors
Iowa State University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Masking description
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.
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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 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 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 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 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. |
| 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. |
Countries
United States
Outcome results
None listed