Iron Supplementation and Side Effects

Iron Deficiency Anemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04018300
• Other study ID #: SEAS
• Status: Completed
• Phase: N/A
• Start date: January 8, 2018
• Est. completion date: April 18, 2018

Study information

• Verified date: July 2019
• Source: Iowa State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: April 18, 2018
• Est. primary completion date: April 18, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Iron Deficiency Anemia
• Iron Overload

Intervention

Dietary Supplement:
• Ferrous sulfate
65 mg Fe as ferrous sulfate
• Aspiron
65 mg Fe as iron-enriched koji culture, called AspironTM

Other:
• Placebo
Contains maltodextrin.

Locations

Country	Name	City	State
United States	Iowa State University	Ames	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Iowa State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the serum iron curve over 8 hours	Serum iron concentrations (µM) measured over 8 hours following consumption of either Ultimine, FeSO4, or placebo capsules at baseline (0h).	0,1,2,3,4,6 and 8 hours
Primary	Area under the NTBI curve over 8 hours	NTBI (µM) concentrations measured over 8 hours following consumption of either Ultimine, FeSO4, or placebo capsules at baseline (0h).	0,1,2,3,4,6 and 8 hours
Primary	Area under the percent transferrin saturation curve over 8 hours	Percent transferrin (%) saturation concentrations measured over 8 hours following consumption of either Ultimine, FeSO4, or placebo capsules at baseline (0h).	0,1,2,3,4,6 and 8 hours
Secondary	Change in protein carbonyls	Change from baseline to 21 days of protein carbonyls (nmol/mL) oxidative stress after taking either Ultimine, FeSO4, or placebo for 3 consecutive weeks.	Baseline and 21 days
Secondary	Change in thiobarbituric acid reactive substances (TBARS)	Change from baseline to 21 days of TBARS (µM) oxidative stress after taking either Ultimine, FeSO4, or placebo for 3 consecutive weeks.	Baseline and 21 days
Secondary	Change in hepcidin	Change from baseline to 21 days of inflammatory status via hepcidin (ng/mL) after taking either Ultimine, FeSO4, or placebo for 3 consecutive weeks.	Baseline and 21 days
Secondary	Change in C-reactive protein	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.	Baseline and 21 days
Secondary	Change in serum ferritin	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.	Baseline and 21 days
Secondary	Change in hemoglobin	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.	Baseline and 21 days
Secondary	Change in hematocrit	Change from baseline to 21 days of iron status through hematocrit (%) production after taking either Ultimine, FeSO4, or placebo for 3 consecutive weeks.	Baseline and 21 days
Secondary	Change in soluble transferrin receptor (sTFR)	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.	Baseline and 21 days
Secondary	Change in total iron binding capacity (TIBC)	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.	Baseline and 21 days
Secondary	Change in glomerular filtration rate (eGFR)	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.	Baseline and 21 days
Secondary	Change in creatinine	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.	Baseline and 21 days
Secondary	Change in blood urea nitrogen (BUN)	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.	Baseline and 21 days
Secondary	Change in aspartate aminotransferase (AST)	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.	Baseline and 21 days
Secondary	Change in alanine aminotransferase (ALT)	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.	Baseline and 21 days
Secondary	Gastrointestinal symptoms	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.	21 days