An interventional study of Cast Iron Pot and Alumnium Pot in Iron-deficiency Anemia, sponsored by Weill Medical College of Cornell University. Terminated at 1 site in United States. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-30.
Sponsored by Weill Medical College of Cornell University · Not applicable, Interventional, and Treatment
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.
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.
1,733 studies on the registry are indexed under Anemia; 246 are open to participants now.
This study's enrollment of 34 is below the median of 94 across 1,291 interventional studies indexed under Anemia.
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Of its 119 completed or terminated interventional studies of FDA-regulated products, 91 (76%) have results posted.
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Exclusion Criteria:
The treatment arm will receive a 12 inch pre seasoned cast iron pot
Device: Cast Iron Pot
12 inch nonstick aluminum fry pan
Device: Alumnium Pot
Cast iron pot
Also known as: Lodge L10SK3 12" Pre-Seasoned Cast Iron Skillet
Aluminum Skillet
Also known as: Alumnium Skillet
Increased hematocrit in second and third trimesters of pregnancy
Time frame: 28 weeks (2nd and 3rd trimesters of pregnancy)
Compliance assessment
We will assess compliance with iron/aluminium pot use at the conclusion of the study
Time frame: postpartum, after ~30 weeks
Incidence of adverse effects
Will contact patients to assess incidence of adverse effects of iron including constipation
Time frame: Monthly phone surveys for 28 weeks
Satisfaction
Will contact patient monthly to assess satisfaction with study intervention
Time frame: Monthly phone surveys for 28 weeks
Maternal anemia postpartum
Will assess subjects need for transfusion and/or symptoms of anemia (dizziness, lightheadedness) postpartum
Time frame: postpartum, after ~30 weeks
Neonatal outcomes
Will follow up neonatal outcomes to assess for prematurity and/or low birthweight
Time frame: postpartum, at ~30 weeks
Plan to share: Undecided — Deidentified data may be shared. No biologic specimens are being collected in this study
No publications or documents are linked to this record.
This study is terminated, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Weill Medical College of Cornell University