Mount Sinai West
New York, 10019, United States
NCT Number: NCT03562143
Iron deficiency is thought to be the most common nutrient deficiency among pregnant women and the most common cause of anemia in pregnancy. The consequences of iron deficiency anemia are serious and can include diminished intellectual and productive capacity and possibly increased susceptibility to infection in mothers and infants, low birthweight, and premature births, hence the importance of appropriate treatment during pregnancy.
Most guidelines recommend an increase in iron consumption by about 15-30 mg/day, an amount readily met by most prenatal vitamin formulations. This is adequate supplementation for non-anemic and non-iron-deficient women. However, women with iron deficiency anemia should receive an additional 30-20 mg/day until the anemia is corrected.
It is not clear whether intermittent administration of oral iron is equivalent to once daily to rise the hemoglobin levels in pregnant women with iron deficiency anemia. Alternate day treatment with supplemental iron has been suggested as a way to improve its absorption because daily doses may suppress the mucosal uptake of iron even in the presence of iron deficiency until the intestinal mucosa completes its turnover.
Another possible factor associated with the frequency of iron dosing is related to hepcidin, the central regulatory molecule in the metabolism of iron in mammals. The synthesis of hepcidin is controlled by 3 kinds of signals: inflammation; the need for increased erythropoiesis, and an iron status signal based on plasma iron levels and iron stores. If plasma iron levels or iron stores are increased, the resulting signal increases hepcidin levels, thereby blocking iron absorption and its release from stores (liver, macrophages) and preventing iron overload.This hepcidin effect, suppressing iron absorption, could last as long as 48h.
In this study, the researchers aim to determine if alternate day dosing of iron in pregnant women with iron deficiency anemia results in improved levels of hemoglobin or hematocrit and ferritin.
Hepcidin levels will be compared between patients on daily iron supplementation versus alternate day supplementation.
The researchers will also evaluate if alternate day dosing of iron supplementation results in a better side effect profile, and with better patient compliance.
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Notify Me18 year–64 year
Female
Interventional
Not applicable
New York, 10019, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients will also be required to have a normal HB electrophoresis; this is a routine test obtained on all prenatal patients.
Exclusion criteria
Patients will take iron supplementation given as 2 tabs of 325 mg ferrous sulfate (equivalent to 130 mg of elemental iron) on alternate day for 6 weeks.
Other names: Alternate-day iron supplementation
Time frame: baseline and 6 weeks
The change in the level of hemoglobin in pregnant patients with iron deficiency anemia after 6 weeks of treatment with either daily or alternate-day iron supplementation.
Time frame: baseline and 6 weeks
Change in the level of ferritin in pregnant patients with iron deficiency anemia after 6 weeks of treatment with either daily or alternate-day iron supplementation.
Time frame: Baseline and Day 43 post treatment
At the end of the 6 weeks of treatment, hepcidin levels will be obtained on day 43 of the study. The 6-week hepcidin level will be compared to the starting hepcidin which will be drawn prior to initiating iron supplementation.
Time frame: 6 weeks
Patients will be asked to fill a questionnaire after 6 weeks to assess for adverse symptoms associated with consumption of iron including constipation, nausea, vomiting, diarrhea, abdominal pain, and headache. Each of these items is scaled from 0 (not al all) to 10 (very much), with total scale from 0-60, with higher score indicating more severe symptoms.
Icahn School of Medicine at Mount Sinai
Other
Daily vs Alternate Day Iron Supplementation for Pregnant Women With Iron Deficiency Anemia: A Randomized Controlled
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