Iron-deficiency AnemiaNCT02341300
Use of Cast Iron Pots to Improve Maternal Anemia
A study testing Cast Iron Pot and Alumnium Pot in people with Iron-deficiency Anemia, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
Anemia of pregnancy is defined as a hemoglobin concentration of less than 11 g/dL in the first and third trimesters, and less than 10.5 g/dL in the second trimester. The rates of anemia are variable and depend largely on preexisting iron stores and supplementation. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron-deficiency Anemia
- What is being tested?
- Cast Iron Pot and Alumnium Pot
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2020to 15 Jul 2020
- 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 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women of any age in their first trimester of pregnancy with anemia defined as a Hemoglobin less than 11 and/or a hematocrit less than 33
- Willingness and ability to cook in provided cast iron pot at least 3x/week
- Singleton gestations
Who cannot join
- Any secondary cause of anemia including inherited and acquired hemolytic anemias (sickle cell disease, thalessemia, malaria, etc) Inability or unwillingness to try to use cast iron pot approximately 3x/week
- Women with severe chronic illness and high likelihood of preterm birth and/or expected long-term hospitalizations during pregnancy. Multifetal gestations
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Prebyterian Hospital Weill Cornell
New York, New York, 10021
About this study
Anemia of pregnancy is defined as a hemoglobin concentration of less than 11 g/dL in the first and third trimesters, and less than 10.5 g/dL in the second trimester. The rates of anemia are variable and depend largely on preexisting iron stores and supplementation. Estimates from the World Health Organization report that 35% to 75% of pregnant women in developing countries and 18% of women from industrialized countries are anemic. Maternal anemia is associated with an increased risk of preterm birth, low birthweight, and small for gestational age infants. Many studies have shown improvement in these outcomes with maternal iron supplementation in cases of iron-deficiency anemia. Mounting evidence also indicates that maternal iron deficiency in pregnancy reduces fetal iron stores, perhaps well into the first year of life.
Anemia in pregnancy can also impact maternal morbidity and mortality. Viteri reported that anemic pregnant women are at greater risk of death during the perinatal period and that anemia is the major contributory or sole cause of death in 20-40% of the 500,000 maternal deaths per year.
Read more
The need for iron averages close to 1000mg in a typical singleton gestation. This amount considerably exceeds the iron stores of most women and will result in iron-deficiency anemia unless supplemental iron is taken. One problem with iron supplement use is compliance, secondary to adverse effects such as constipation and nausea. Research on the use of cast iron pots in decreasing the incidence of iron-deficiency anemia in non-pregnant women has been promising. These studies have demonstrated good compliance with no reported adverse effects. The aim of our study is to determine if providing anemic women in the first trimester of pregnancy with a cast iron pot will decrease the incidence of anemia later in pregnancy.
Hypothesis: Cooking in cast iron pots will increase hematocrit levels in pregnancy.
Read the detailed description
Research Question: Will the addition of cast iron pots to the standard of care (nutrition counseling, food recall, prenatal vitamin, +/- iron and vit c) improve the hematocrit of pregnant women with anemia? Study Intervention: To provide a cast iron pot to those pregnant women with anemia who are randomized to intervention group and an aluminum pot to those women in the control group. Women will be blinded to their allocation. Women with a qualifying hemoglobin will meet with our nutritionist (as they would if not enrolled in the study), and she will perform a standardized 24 hour food recall and nutrition counseling according to the standard of care, as well as perform written informed consent. The 24 hour food recall will be submitted to the manufacturer (Nutrition Quest) to calculate the baseline iron intake of each subject. Subjects will be enrolled only if they can agree to incorporate the provided pot into their cooking (in any capacity) 3x/week. Subjects will be called 1x/month and asked about the frequency of pot use over the past month as well as their compliance with iron and vitamin C supplements, if prescribed. Subjects will then also be contacted postpartum to determine satisfaction with the intervention.
Outcome measure: We will be looking at hemoglobin levels in the first, second, and third trimester as well as postpartum (which are all routinely collected labs in pregnancy). Ferritin will be added along with routine labs at approximately 19 weeks as this is often performed in the workup of anemia. No labs outside of routine maternal labs will be performed.
- Conditions
- Iron-deficiency Anemia
- Being tested
- Cast Iron Pot, Alumnium Pot
- Keywords
- Pregnancy, Cast-Iron pots, Iron-deficiency anemia
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cast Iron PotDevice
Also called Lodge L10SK3 12" Pre-Seasoned Cast Iron Skillet
Cast iron pot
Alumnium PotDevice
Also called Alumnium Skillet
Aluminum Skillet
| Study group | Role | What they receive |
|---|---|---|
| Cast-Iron Pot | Experimental | The treatment arm will receive a 12 inch pre seasoned cast iron pot Receives: Device: Cast Iron Pot |
| Aluminum Pot | Placebo comparator | 12 inch nonstick aluminum fry pan Receives: Device: Alumnium Pot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increased hematocrit in second and third trimesters of pregnancy
Measured: 28 weeks (2nd and 3rd trimesters of pregnancy)
Secondary outcomes (5)
Compliance assessment
We will assess compliance with iron/aluminium pot use at the conclusion of the study
Measured: postpartum, after ~30 weeks
Incidence of adverse effects
Will contact patients to assess incidence of adverse effects of iron including constipation
Measured: Monthly phone surveys for 28 weeks
Satisfaction
Will contact patient monthly to assess satisfaction with study intervention
Measured: Monthly phone surveys for 28 weeks
Maternal anemia postpartum
Will assess subjects need for transfusion and/or symptoms of anemia (dizziness, lightheadedness) postpartum
Measured: postpartum, after ~30 weeks
Neonatal outcomes
Will follow up neonatal outcomes to assess for prematurity and/or low birthweight
Measured: postpartum, at ~30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2015 (estimated)
- Study start15 Jul 2020
- Primary completion15 Jul 2020
- Study completion15 Jul 2020
Why it stopped: Original investigator has left the institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron-deficiency AnemiaStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen Chasen, MD, Principal investigator, New York Presbyterian Hospital Weill Cornell
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02341300
- Sponsor's protocol ID
- 1310014372
- Status last verified
- Jul 2020
- First submitted
- 30 Jul 2014
- Last updated
- 30 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Deidentified data may be shared. No biologic specimens are being collected in this study
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Cast Iron Pots to Improve Maternal Anemia
- ClinicalTrials.gov ID
- NCT02341300
- Acronym / sponsor ID
- 1310014372
- Conditions
- Iron-deficiency Anemia
- Keywords
- Pregnancy, Cast-Iron pots, Iron-deficiency anemia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Original investigator has left the institution.
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 15 Jul 2020 (actual)
- Study completion
- 15 Jul 2020 (actual)
- First posted
- 19 Jan 2015 (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.
Anemia of pregnancy is defined as a hemoglobin concentration of less than 11 g/dL in the first and third trimesters, and less than 10.5 g/dL in the second trimester. The rates of anemia are variable and depend largely on preexisting iron stores and supplementation. Estimates from the World Health Organization report that 35% to 75% of pregnant women in developing countries and 18% of women from industrialized countries are anemic. Maternal anemia is associated with an increased risk of preterm birth, low birthweight, and small for gestational age infants. Many studies have shown improvement in these outcomes with maternal iron supplementation in cases of iron-deficiency anemia. Mounting evidence also indicates that maternal iron deficiency in pregnancy reduces fetal iron stores, perhaps well into the first year of life.
Anemia in pregnancy can also impact maternal morbidity and mortality. Viteri reported that anemic pregnant women are at greater risk of death during the perinatal period and that anemia is the major contributory or sole cause of death in 20-40% of the 500,000 maternal deaths per year.
The need for iron averages close to 1000mg in a typical singleton gestation. This amount considerably exceeds the iron stores of most women and will result in iron-deficiency anemia unless supplemental iron is taken. One problem with iron supplement use is compliance, secondary to adverse effects such as constipation and nausea. Research on the use of cast iron pots in decreasing the incidence of iron-deficiency anemia in non-pregnant women has been promising. These studies have demonstrated good compliance with no reported adverse effects. The aim of our study is to determine if providing anemic women in the first trimester of pregnancy with a cast iron pot will decrease the incidence of anemia later in pregnancy.
Hypothesis: Cooking in cast iron pots will increase hematocrit levels in pregnancy.
Detailed description
Research Question: Will the addition of cast iron pots to the standard of care (nutrition counseling, food recall, prenatal vitamin, +/- iron and vit c) improve the hematocrit of pregnant women with anemia? Study Intervention: To provide a cast iron pot to those pregnant women with anemia who are randomized to intervention group and an aluminum pot to those women in the control group. Women will be blinded to their allocation. Women with a qualifying hemoglobin will meet with our nutritionist (as they would if not enrolled in the study), and she will perform a standardized 24 hour food recall and nutrition counseling according to the standard of care, as well as perform written informed consent. The 24 hour food recall will be submitted to the manufacturer (Nutrition Quest) to calculate the baseline iron intake of each subject. Subjects will be enrolled only if they can agree to incorporate the provided pot into their cooking (in any capacity) 3x/week. Subjects will be called 1x/month and asked about the frequency of pot use over the past month as well as their compliance with iron and vitamin C supplements, if prescribed. Subjects will then also be contacted postpartum to determine satisfaction with the intervention.
Outcome measure: We will be looking at hemoglobin levels in the first, second, and third trimester as well as postpartum (which are all routinely collected labs in pregnancy). Ferritin will be added along with routine labs at approximately 19 weeks as this is often performed in the workup of anemia. No labs outside of routine maternal labs will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cast-Iron Pot | Experimental | Device: Cast Iron PotThe treatment arm will receive a 12 inch pre seasoned cast iron pot |
| Aluminum Pot | Placebo comparator | Device: Alumnium Pot12 inch nonstick aluminum fry pan |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pregnant women of any age in their first trimester of pregnancy with anemia defined as a Hemoglobin less than 11 and/or a hematocrit less than 33
- Willingness and ability to cook in provided cast iron pot at least 3x/week
- Singleton gestations
Key exclusion criteria (2 listed)
- Any secondary cause of anemia including inherited and acquired hemolytic anemias (sickle cell disease, thalessemia, malaria, etc) Inability or unwillingness to try to use cast iron pot approximately 3x/week
- Women with severe chronic illness and high likelihood of preterm birth and/or expected long-term hospitalizations during pregnancy. Multifetal gestations
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 |
|---|---|---|
| Cast Iron PotAlso: Lodge L10SK3 12" Pre-Seasoned Cast Iron SkilletCast iron pot | Device | Cast-Iron Pot |
| Alumnium PotAlso: Alumnium SkilletAluminum Skillet | Device | Aluminum Pot |
Primary outcome
Increased hematocrit in second and third trimesters of pregnancy
Time frame: 28 weeks (2nd and 3rd trimesters of pregnancy)
5 secondary outcomes
Compliance assessment
Time frame: postpartum, after ~30 weeks
Incidence of adverse effects
Time frame: Monthly phone surveys for 28 weeks
Satisfaction
Time frame: Monthly phone surveys for 28 weeks
Maternal anemia postpartum
Time frame: postpartum, after ~30 weeks
Neonatal outcomes
Time frame: postpartum, at ~30 weeks
Results and safety
The study was stopped early (reason given: Original investigator has left the institution.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2020.
- Individual participant dataSharing planned: Undecided. Deidentified data may be shared. No biologic specimens are being collected in this study
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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.
Stephen Chasen, MD principal investigator
New York Presbyterian Hospital Weill Cornell
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cast Iron Pot and Alumnium Pot in people with Iron-deficiency Anemia, run by Weill Medical College of Cornell University 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 3 inclusion and 2 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: stopped early, as of the sponsor's last update on 30 Jul 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Original investigator has left the institution.). Results are not available in the source record.
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?
Increased hematocrit in second and third trimesters of pregnancy (time frame: 28 weeks (2nd and 3rd trimesters of pregnancy)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jul 2020.