Effect of Vitamin C on Iron Absorption

June 24, 2020 updated by: Steve Abrams, MD, Baylor College of Medicine

Effect of Ascorbic Acid on Iron Absorption From Ferrous Fumarate

Iron deficiency is a common health problem worldwide. Ferrous fumarate (a form of iron) is often added to foods in an effort to prevent iron deficiency. Vitamin C can improve the amount of iron that the body absorbs, therefore it is often added to foods too. However, we don't know if vitamin C really increases the absorption of iron from ferrous fumarate.

This study will measure the iron absorption in children from a meal containing some ferrous fumarate with and without vitamin C. The study will include 4 visits to the Children's Nutrition Research Center in Houston, TX.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study involves four outpatient visits. Two test meals will be given (during visits 2 and 3) and two blood draws will be done (visits 3 and 4). A 2-3 hour fast prior to the visit is required. Therefore, subjects may come in first thing in the morning (for breakfast meal), at lunch, or in the afternoon (snack). Subjects may be scheduled to come in during the week or on weekends; however, each individual subject will need to return at the same time of day for each subsequent visit. Visit procedures are described below.

Visit 1: Subjects will be admitted to the GCRC as an outpatient after a 2-3h fast and given a reference dose of 1mg iron-58 sulfate as an aqueous solution with 50mg ascorbic acid. They will be observed for 2h after this dose and water will be freely available. No food will be allowed. After 2h subjects will be discharged home and food allowed.

Visit 2: One to 10 days later subjects will be again admitted as an outpatient after a 2-3h fast. They will consume a meal of a bread muffin labelled with 4mg of iron-57 as ferrous fumarate, and a glass of apple juice containing 0 or 25mg ascorbic acid. The order of ascorbic acid supplementation or non-supplementation will be decided by random. No food will be allowed after the meal. After 2h subjects will be discharged home and food allowed.

Visit 3: Two weeks (+/- 3 days) later they will be readmitted after a 2-3h fast and the second visit repeated. During this admission the apple juice will contain either 0 or 25mg ascorbic acid, the opposite of what was given to the subject in visit 2. Immediately prior to administration of the second test meal, 10mL blood will be drawn for measurement of iron nutritional parameters (e.g. CBC, serum ferritin) and iron isotope ratio measurement. Incorporation of iron-57 will be used to calculate iron absorption from the test meal given during visit 2, and incorporation of iron-58 used to measure absorption from the reference dose (a measure of iron status). No food will be allowed after the meal and blood draw. After 2h subjects will be discharged home and food allowed.

Visit 4: Two weeks (+/- 3 days) later subjects will be admitted for a 10mL blood draw as described above. Incorporation of iron-57 will reflect the absorption of ferrous fumarate from the test meal given during visit 3.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77057
        • Children's Nutrition Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 months to 4 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy children
  • 4-8.0y of age
  • No chronic medical problems
  • Not on regular medications
  • Subjects on vitamin or mineral supplementation will be eligible as long as they discontinue the supplements two weeks prior to the first visit, until the end of the fourth visit.

Exclusion Criteria:

  • Chronic medical problems that interfere with nutrient absorption
  • History of prematurity (<37 wks gestational age)
  • History of birth weight <2500g
  • Current height-for-age or weight-for-age below the 5th centile or above the 95th centile

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: A
Subjects in Arm A will receive the juice without ascorbic acid in addition to the muffin with ferrous fumarate.
Dietary supplement: Vitamin C

Visit 1: Subjects will receive 1mg iron-58 sulfate as an aqueous solution with 50mg ascorbic acid.

Visit 2: Subjects will consume a meal of a bread muffin labelled with 4mg of iron-57 as ferrous fumarate, and a glass of apple juice containing 0 or 25mg ascorbic acid.

Visit 3: During this admission the apple juice will contain either 0 or 25mg ascorbic acid, the opposite of what was given to the subject in visit 2.
Active Comparator: B
Subjects in Arm A will receive the juice with 25mg ascorbic acid in addition to the muffin with ferrous fumarate
Dietary supplement: Vitamin C

Visit 1: Subjects will receive 1mg iron-58 sulfate as an aqueous solution with 50mg ascorbic acid.

Visit 2: Subjects will consume a meal of a bread muffin labelled with 4mg of iron-57 as ferrous fumarate, and a glass of apple juice containing 0 or 25mg ascorbic acid.

Visit 3: During this admission the apple juice will contain either 0 or 25mg ascorbic acid, the opposite of what was given to the subject in visit 2.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Clarify the effect, if any, of ascorbic acid on ferrous fumarate absorption
Time Frame: 2 weeks
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Baylor College of Medicine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Steven A Abrams, MD, Baylor College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 7, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 11, 2007

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 26, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H-21063

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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