Iron DeficiencyNCT00570895
Effect of Vitamin C on Iron Absorption
A study testing Vitamin C in people with Iron Deficiency, run by Baylor College of Medicine at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 4 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency
- What is being tested?
- Vitamin C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to May 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Nutrition Research Center
Houston, Texas, 77057
About this study
Official title: 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.
Read the 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.
- Conditions
- Iron Deficiency
- Being tested
- Vitamin C
- Keywords
- Iron, Absorption, Ascorbic Acid, Ferrous Fumarate
- Medical subject headings
- Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin CDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Subjects in Arm A will receive the juice without ascorbic acid in addition to the muffin with ferrous fumarate. Receives: Dietary Supplement: Vitamin C |
| B | Active comparator | Subjects in Arm A will receive the juice with 25mg ascorbic acid in addition to the muffin with ferrous fumarate Receives: Dietary Supplement: Vitamin C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clarify the effect, if any, of ascorbic acid on ferrous fumarate absorption
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2007 (estimated)
- Study startJan 2008
- Primary completionApr 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Iron DeficiencyStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steve Abrams, MD, Baylor College of Medicine
- Investigators
- Steven A Abrams, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00570895
- Sponsor's protocol ID
- H-21063
- Status last verified
- Jun 2020
- First submitted
- 7 Dec 2007
- Last updated
- 26 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Balay KS, Hawthorne KM, Hicks PD, Griffin IJ, Chen Z, Westerman M, Abrams SA. Orange but not apple juice enhances ferrous fumarate absorption in small children. J Pediatr Gastroenterol Nutr. 2010 May;50(5):545-50. doi: 10.1097/MPG.0b013e3181b1848f.
PubMed 20639713
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ascorbic Acid on Iron Absorption From Ferrous Fumarate
- ClinicalTrials.gov ID
- NCT00570895
- Acronym / sponsor ID
- H-21063
- Conditions
- Iron Deficiency
- Keywords
- Iron, Absorption, Ascorbic Acid, Ferrous Fumarate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Apr 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 11 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Dietary Supplement: Vitamin CSubjects in Arm A will receive the juice without ascorbic acid in addition to the muffin with ferrous fumarate. |
| B | Active comparator | Dietary Supplement: Vitamin CSubjects in Arm A will receive the juice with 25mg ascorbic acid in addition to the muffin with ferrous fumarate |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin CVisit 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. | Dietary supplement | A, B |
Primary outcome
Clarify the effect, if any, of ascorbic acid on ferrous fumarate absorption
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2020.
- Derived from this study: PubMed 20639713Balay KS, Hawthorne KM, Hicks PD, Griffin IJ, Chen Z, Westerman M, Abrams SA. Orange but not apple juice enhances ferrous fumarate absorption in small children. J Pediatr Gastroenterol Nutr. 2010 May;50(5):545-50. doi: 10.1097/MPG.0b013e3181b1848f.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven A Abrams, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin C in people with Iron Deficiency, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clarify the effect, if any, of ascorbic acid on ferrous fumarate absorption (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00570895, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2020.