Daily vs Alternate Day Iron Supplementation for Pregnant Women With Iron Deficiency Anemia
| Status: | Recruiting |
|---|---|
| Conditions: | Iron Deficiency Anemia, Anemia, Anemia |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 18 - 64 |
| Updated: | 2/28/2019 |
| Start Date: | August 31, 2018 |
| End Date: | July 28, 2020 |
| Contact: | Melissa T Chu Lam, MD |
| Email: | melissa.chulam@mountsinai.org |
| Phone: | 520-360-8807 |
Daily vs Alternate Day Iron Supplementation for Pregnant Women With Iron Deficiency Anemia: A Randomized Controlled
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.
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.
Inclusion Criteria:
- Pregnant patients with iron deficiency anemia, defined as Hb less than 11.0 or
hematocrit less than 33% with ferritin 25 ug/L
- Age 18-64 years old.
- Gestational age between 12 0/7 weeks and 34 0/7 weeks.
- No other known causes of anemia (Folate or vit b12 deficiency anemia, sideroblastic
anemia, thalassemia, sickle cell anemia, aplastic anemia, hemolytic anemia, anemia of
chronic disease). Anemic patients with a low ferritin level and a mean corpuscular
volume (MCV) >95 will have folate and vitamin B12 measured since some patients might
have combined causes of anemia and might not respond as expected to iron
supplementation only.
Patients will also be required to have a normal HB electrophoresis; this is a routine test
obtained on all prenatal patients.
Exclusion Criteria:
- Patients currently receiving iron supplementation
- Malabsorptive and restrictive bariatric surgery
- Inflammatory bowel disease
- Irritable bowel syndrome
- Celiac disease/atrophic gastritis/Helicobacter pylori
- Active infection (ferritin can be falsely elevated since apoferritin is an acute-phase
protein like CRP and increases both during infections and inflammatory reactions eg
postoperatively).
- Patients with contraindications to iron supplementation such as iron overload or
hypersensitivity
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