Iron AbsorptionNCT01489007
Iron Absorption in Vegetarian Children
An observational study of Iron Absorption, run by Baylor College of Medicine at 1 site in United States.
Trial summary
Few areas are more controversial in pediatric nutrition than the role of a vegetarian diet for children. Advocates make strong health claims whereas others have expressed safety concerns, especially regarding iron nutrition. Read more about this study
- Who is it for?
- Ages 4 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Iron Absorption
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Dec 2014
- Phase
- Observational
- 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 10 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Community sample
Who may be able to join
- Delivery at > or = 35.0 weeks gestation with birth weight > or = 2.5 kg
- BMI: 10th - 90th percentile for age and gender
- Ages 4.0 to 10.9 years
- Ethnic distribution of greater Houston area
- Self-described lacto-ovo vegetarians for the past 6 months (Subjects who include a small amount of fish or chicken in the diet (not more than 2 servings total/week of both combined) will be allowed to participate in this study as these are not major iron contributors to the diet. Subjects must not have eaten any "red meat" however for 6 months.) Control subjects will be non-vegetarians.
- Any regularly taken (daily) iron supplements (with or without vitamin D) must be stopped at least 1 month before starting the study. Supplements of vitamin D with calcium, B12, and folate are allowed.
Who cannot join
- History of any chronic illness.
- Regularly taken (daily) medications (except seasonal allergies).
- Avoidance of dairy products in the diet (controls excluded).
- Females: has had first menstrual period.
- Control subjects will be non-vegetarians whose usual diet includes 2 servings/week or more of red meat.
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor College of Medicine / Texas Children's Hospital
Houston, Texas, 77030
About this study
Official title: Evaluation of Iron Absorption in Healthy Vegetarian Children 4 to 10 Years of Age
Few areas are more controversial in pediatric nutrition than the role of a vegetarian diet for children. Advocates make strong health claims whereas others have expressed safety concerns, especially regarding iron nutrition. The frequency of vegetarianism among children is said to be rapidly increasing although clear data are not available. Surveys of children in the US age 8 to 18 reported in the media find that about 3-5% of children are lacto-ovo vegetarian, with some fish or chicken products in the diet. This is a substantial proportion that is very likely to increase over the next few years with essentially no nutrient metabolism data related to this population.
One of the principal concerns with a lacto-ovo vegetarian diet, as preferred by many children, is the lack of heme iron in the diet. A key question that can be evaluated in children is whether iron status is in fact affected by a lacto-ovo vegetarian diet.
Read more
According to the American Academy of Pediatrics (AAP Pediatric Nutrition Handbook, 6th Edition, 2008), vegetarian diets can provide appropriate nutrition for children. Depending on the level of dietary restriction, fortified foods or supplements may be necessary during different life stages. In addition, strict vegetarian children may have slightly higher protein needs compared to non-vegetarian children due to decreased protein digestibility in certain plants. The AAP further recommends that children 4-8 years old consume a minimum of five servings per day of beans/nuts/seeds/eggs and six servings per day of calcium-rich foods.
To evaluate this issue, the investigators will use a stable isotope method to directly assess iron status. It is increasingly recognized that the ability to absorb iron when given with vitamin C is a highly accurate measurement of iron status and may be a true gold standard in this regard. In this planned study, investigators will be able to assess both reference dose iron absorption and standard biochemical markers of iron status in a group of lacto-ovo vegetarians and compare them with age- and gender-matched children on a non-vegetarian diet. These data can be important in determining if iron status is decreased in lacto-ovo vegetarians and will serve as a basis for future interventions and evaluations if a difference is found.
Read the detailed description
Iron absorption studies will be done in 30 healthy vegetarian children 4 to 10 yrs of age and 30 healthy non-vegetarian children who are age and gender matched controls (from another study).
Visit 1: At the time of enrollment, subjects and their families will be asked to come to the General Clinical Research Center (GCRC) of Texas Children's Hospital or the Metabolic Research Unit (MRU) at the Children's Nutrition Research Center for a screening visit. Prior to this visit, demographics from the parent/guardian will be recorded including the child's approximate height and weight, and the study dietitian will obtain two 24-hour dietary recalls from the parent to determine dietary intake for enrollment. During this screening visit, informed written consent will be obtained and anthropometry and vital signs will be recorded.
The study dietitian will instruct the parent/guardian and child on the use of a food scale to weigh and record dietary intake for a 3-day period (ie, 3-day weighed diet record). The 3-day weighed diet record will begin the following day. Upon analysis of their child's intake, parents will be instructed to maintain a similar nutrient intake throughout the study. Compliance will be monitored via 3-day weighed home diet records timed with their other study visits. If analysis shows that the child's intake has significantly changed (± 20% of a nutrient), the parent will be counseled by the study dietitian on readjusting the child's intake back to the usual level determined at baseline.
Visit 2: Subjects will be admitted to the GCRC or MRU 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 however water is allowed. After 2h subjects will be discharged home and food allowed. After discharge, subjects will record dietary intake using another 3-day weighed diet record.
Visit 3: Prior to this visit, subjects will receive a food scale and will perform another 3-day weighed diet record to demonstrate consistency of diet throughout the study period. Two weeks (+/- 3 days) later subjects will be readmitted and 10mL blood (2 tsp) will be drawn for measurement of iron nutritional parameters (e.g. hepcidin, ferritin, iron, TIBC, transferrin saturation, hemoglobin, hematocrit, and RBC indices) and iron isotope ratio measurement. Labs for iron nutritional parameters may be sent to the TCH Lab or an outside commercial lab. Incorporation of iron-58 will be used to measure absorption from the reference dose (a measure of iron status). Topical numbing cream or spray to minimize pain at the injection site will be offered to all subjects.
- Conditions
- Iron Absorption
- Keywords
- vegetarian, children, iron, iron absorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Vegetarian Children | Self-described lacto-ovo vegetarians for the past 6 months (Subjects who include a small amount of fish or chicken in the diet (not more than 2 servings total/week of both combined) will be allowed to participate in this study as these are not major iron contributors to the diet. Subjects must not have eaten any "red meat" however for 6 months.) Control subjects will be non-vegetarians. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of vegetarian diet on iron status
At the final study visit, 10 mL blood (2 tsp) will be drawn for measurement of iron nutritional parameters (e.g. hepcidin, ferritin, iron, TIBC, transferrin saturation, hemoglobin, hematocrit, and RBC indices) and iron isotope ratio measurement.
Measured: At the final study visit (approximately 3-4 weeks after the start of the study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Iron AbsorptionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 29 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 Abrams, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01489007
- Sponsor's protocol ID
- H-29640
- Status last verified
- Jun 2020
- First submitted
- 7 Dec 2011
- Last updated
- 26 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Thane CW, Bates CJ, Prentice A. Risk factors for low iron intake and poor iron status in a national sample of British young people aged 4-18 years. Public Health Nutr. 2003 Aug;6(5):485-96. doi: 10.1079/PHN2002455.
PubMed 12943565Craig WJ, Mangels AR; American Dietetic Association. Position of the American Dietetic Association: vegetarian diets. J Am Diet Assoc. 2009 Jul;109(7):1266-82. doi: 10.1016/j.jada.2009.05.027.
PubMed 19562864
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
- Evaluation of Iron Absorption in Healthy Vegetarian Children 4 to 10 Years of Age
- ClinicalTrials.gov ID
- NCT01489007
- Acronym / sponsor ID
- H-29640
- Conditions
- Iron Absorption
- Keywords
- vegetarian, children, iron, iron absorption
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 9 Dec 2011 (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.
Few areas are more controversial in pediatric nutrition than the role of a vegetarian diet for children. Advocates make strong health claims whereas others have expressed safety concerns, especially regarding iron nutrition. The frequency of vegetarianism among children is said to be rapidly increasing although clear data are not available. Surveys of children in the US age 8 to 18 reported in the media find that about 3-5% of children are lacto-ovo vegetarian, with some fish or chicken products in the diet. This is a substantial proportion that is very likely to increase over the next few years with essentially no nutrient metabolism data related to this population.
One of the principal concerns with a lacto-ovo vegetarian diet, as preferred by many children, is the lack of heme iron in the diet. A key question that can be evaluated in children is whether iron status is in fact affected by a lacto-ovo vegetarian diet.
According to the American Academy of Pediatrics (AAP Pediatric Nutrition Handbook, 6th Edition, 2008), vegetarian diets can provide appropriate nutrition for children. Depending on the level of dietary restriction, fortified foods or supplements may be necessary during different life stages. In addition, strict vegetarian children may have slightly higher protein needs compared to non-vegetarian children due to decreased protein digestibility in certain plants. The AAP further recommends that children 4-8 years old consume a minimum of five servings per day of beans/nuts/seeds/eggs and six servings per day of calcium-rich foods.
To evaluate this issue, the investigators will use a stable isotope method to directly assess iron status. It is increasingly recognized that the ability to absorb iron when given with vitamin C is a highly accurate measurement of iron status and may be a true gold standard in this regard. In this planned study, investigators will be able to assess both reference dose iron absorption and standard biochemical markers of iron status in a group of lacto-ovo vegetarians and compare them with age- and gender-matched children on a non-vegetarian diet. These data can be important in determining if iron status is decreased in lacto-ovo vegetarians and will serve as a basis for future interventions and evaluations if a difference is found.
Detailed description
Iron absorption studies will be done in 30 healthy vegetarian children 4 to 10 yrs of age and 30 healthy non-vegetarian children who are age and gender matched controls (from another study).
Visit 1: At the time of enrollment, subjects and their families will be asked to come to the General Clinical Research Center (GCRC) of Texas Children's Hospital or the Metabolic Research Unit (MRU) at the Children's Nutrition Research Center for a screening visit. Prior to this visit, demographics from the parent/guardian will be recorded including the child's approximate height and weight, and the study dietitian will obtain two 24-hour dietary recalls from the parent to determine dietary intake for enrollment. During this screening visit, informed written consent will be obtained and anthropometry and vital signs will be recorded.
The study dietitian will instruct the parent/guardian and child on the use of a food scale to weigh and record dietary intake for a 3-day period (ie, 3-day weighed diet record). The 3-day weighed diet record will begin the following day. Upon analysis of their child's intake, parents will be instructed to maintain a similar nutrient intake throughout the study. Compliance will be monitored via 3-day weighed home diet records timed with their other study visits. If analysis shows that the child's intake has significantly changed (± 20% of a nutrient), the parent will be counseled by the study dietitian on readjusting the child's intake back to the usual level determined at baseline.
Visit 2: Subjects will be admitted to the GCRC or MRU 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 however water is allowed. After 2h subjects will be discharged home and food allowed. After discharge, subjects will record dietary intake using another 3-day weighed diet record.
Visit 3: Prior to this visit, subjects will receive a food scale and will perform another 3-day weighed diet record to demonstrate consistency of diet throughout the study period. Two weeks (+/- 3 days) later subjects will be readmitted and 10mL blood (2 tsp) will be drawn for measurement of iron nutritional parameters (e.g. hepcidin, ferritin, iron, TIBC, transferrin saturation, hemoglobin, hematocrit, and RBC indices) and iron isotope ratio measurement. Labs for iron nutritional parameters may be sent to the TCH Lab or an outside commercial lab. Incorporation of iron-58 will be used to measure absorption from the reference dose (a measure of iron status). Topical numbing cream or spray to minimize pain at the injection site will be offered to all subjects.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vegetarian Children | – | –Self-described lacto-ovo vegetarians for the past 6 months (Subjects who include a small amount of fish or chicken in the diet (not more than 2 servings total/week of both combined) will be allowed to participate in this study as these are not major iron contributors to the diet. Subjects must not have eaten any "red meat" however for 6 months.) Control subjects will be non-vegetarians. |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Community sample
Key inclusion criteria (6 listed)
- Delivery at > or = 35.0 weeks gestation with birth weight > or = 2.5 kg
- BMI: 10th - 90th percentile for age and gender
- Ages 4.0 to 10.9 years
- Ethnic distribution of greater Houston area
- Self-described lacto-ovo vegetarians for the past 6 months (Subjects who include a small amount of fish or chicken in the diet (not more than 2 servings total/week of both combined) will be allowed to participate in this study as these are not major iron contributors to the diet. Subjects must not have eaten any "red meat" however for 6 months.) Control subjects will be non-vegetarians.
Key exclusion criteria (5 listed)
- History of any chronic illness.
- Regularly taken (daily) medications (except seasonal allergies).
- Avoidance of dairy products in the diet (controls excluded).
- Females: has had first menstrual period.
- Control subjects will be non-vegetarians whose usual diet includes 2 servings/week or more of red meat.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Effect of vegetarian diet on iron status
Time frame: At the final study visit (approximately 3-4 weeks after the start of the study)
At the final study visit, 10 mL blood (2 tsp) will be drawn for measurement of iron nutritional parameters (e.g. hepcidin, ferritin, iron, TIBC, transferrin saturation, hemoglobin, hematocrit, and RBC indices) and iron isotope ratio measurement.
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.
- Background: PubMed 12943565Thane CW, Bates CJ, Prentice A. Risk factors for low iron intake and poor iron status in a national sample of British young people aged 4-18 years. Public Health Nutr. 2003 Aug;6(5):485-96. doi: 10.1079/PHN2002455.
- Background: PubMed 19562864Craig WJ, Mangels AR; American Dietetic Association. Position of the American Dietetic Association: vegetarian diets. J Am Diet Assoc. 2009 Jul;109(7):1266-82. doi: 10.1016/j.jada.2009.05.027.
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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 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?
An observational study of Iron Absorption, 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 6 inclusion and 5 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?
Effect of vegetarian diet on iron status (time frame: At the final study visit (approximately 3-4 weeks after the start of the study)). 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 NCT01489007, which also lists 2 linked publications.
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.