Iron Supplementation and Side Effects

NCT04018300 | Completed

• 1 other identifier: SEAS
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Iron Deficiency Anemia; Iron Overload

Keywords

ferrous sulfate; non-transferrin bound iron; oral iron supplement; oral iron supplement side effects

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (15)

• Change in protein carbonyls

  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

Study Arms (3)

Ferrous sulfate

EXPERIMENTAL

Subjects will take a 65 mg Fe capsule of ferrous sulfate, once daily for 21 consecutive days. The first treatment capsule will be consumed with a semi-purified meal (egg albumin, sugar, vanilla, maltodextrose and corn oil) and will have blood drawn hours 0, 1, 2, 3, 4, 6 and 8 post consumption. Serum will be used to determine non-transerrin bound iron, serum iron and percent saturation. Throughout the treatment period, subjects are informed to consume the capsule with food and report symptoms in an online questionnaire. Following three weeks treatment, participants return for a blood draw and oxidative stress indicators are measured. A three week washout period with placebo treatment takes place between treatment crossover.

Dietary Supplement: Ferrous sulfate

Aspiron

EXPERIMENTAL

AspironTM which is an iron-enriched supplement will follow the same guidelines and protocol as ferrous sulfate arm. Equivalent 65 mg Fe per capsule will be administered to participants.

Dietary Supplement: Aspiron

Placebo

PLACEBO COMPARATOR

Participants will follow the same description for the other two experimental treatment groups. Capsules will be given to subjects in opaque formation, therefore will be unable to differentiate the iron supplements.

Other: Placebo

Interventions

Ferrous sulfate DIETARY_SUPPLEMENT

65 mg Fe as ferrous sulfate

Ferrous sulfate

Aspiron DIETARY_SUPPLEMENT

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

Also known as: Aspergillus oryzae

Aspiron

Placebo OTHER

Contains maltodextrin.

Also known as: Starch pill

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Iowa State University: lead

Study Sites (1)

Iowa State University

Ames, Iowa, 50011, United States

Location

Related Publications (1)

• Bries AE, Wang C, Agbemafle I, Wels B, Reddy MB. Assessment of Acute Serum Iron, Non-Transferrin-Bound Iron, and Gastrointestinal Symptoms with 3-Week Consumption of Iron-Enriched Aspergillus oryzae Compared with Ferrous Sulfate. Curr Dev Nutr. 2019 Nov 7;3(12):nzz127. doi: 10.1093/cdn/nzz127. eCollection 2019 Dec.

  PMID: 32154497 DERIVED

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Iron Overload

Interventions

ferrous sulfate; Starch

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Polysaccharides

Study Officials

• Manju B Reddy, PhD

  Iowa State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 3, 2019
• First Posted: July 12, 2019
• Study Start: January 8, 2018
• Primary Completion: April 18, 2018
• Study Completion: April 18, 2018
• Last Updated: July 12, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)