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Completed

NCT Number: NCT04018300

Iron Supplementation and Side Effects

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.

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Key information

Conditions

Iron Deficiency Anemia Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Metabolism Disorders Iron Overload Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Iowa State University

Ames, Iowa, 50011, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ferrous Sulfate

Dietary Supplement

65 mg Fe as ferrous sulfate

Aspiron

Dietary Supplement

65 mg Fe as iron-enriched koji culture, called AspironTM

Other names: Aspergillus oryzae

Placebo

Other

Contains maltodextrin.

Other names: Starch pill

Primary outcomes

  1. 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).

  2. 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).

  3. 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

  1. Change in protein carbonyls

    Time frame: 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.

  2. Change in thiobarbituric acid reactive substances (TBARS)

    Time frame: 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.

  3. Change in hepcidin

    Time frame: 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.

  4. Change in C-reactive protein

    Time frame: 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.

  5. Change in serum ferritin

    Time frame: 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.

  6. Change in hemoglobin

    Time frame: 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.

  7. Change in hematocrit

    Time frame: 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.

  8. Change in soluble transferrin receptor (sTFR)

    Time frame: 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.

  9. Change in total iron binding capacity (TIBC)

    Time frame: 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.

  10. Change in glomerular filtration rate (eGFR)

    Time frame: 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.

  11. Change in creatinine

    Time frame: 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.

  12. Change in blood urea nitrogen (BUN)

    Time frame: 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.

  13. Change in aspartate aminotransferase (AST)

    Time frame: 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.

  14. Change in alanine aminotransferase (ALT)

    Time frame: 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.

  15. Gastrointestinal symptoms

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Iowa State University

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 12, 2019
Registry last updated
Jul 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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