Effect of Ascorbic Acid Supplementation in Pregnancy on Anemia (AAA)
Withdrawn before enrolling · Not applicable · Has a placebo group
Conditions studied: Anemia in Pregnancy
In brief
A. Anemia is a common problem affecting pregnancy and can result in profound consequences to both the mother and the growing fetus. Current treatment usually includes administration of oral or IV iron, or blood transfusions. Vitamin C is known to affect iron metabolism and has been shown to improve outcomes when used in addition to iron, however, few studies have been performed in pregnancy. The primary aim of this study is to identify the effects of vitamin C on anemia in pregnancy. The Investigators propose a double-blind, randomized placebo controlled trial of 1000mg vitamin C supplementation in 200 low risk pregnancies with iron-deficiency anemia. All newly enrolled patients, who meet inclusion and exclusion criteria, will receive the standard of care evaluation and treatment for anemia in pregnancy. Additionally, patients will be randomized to receive either placebo or vitamin C and compliance monitored with a pill diary. Data will be analyzed by T tests and Mann-Whitney U test. If the data shows a positive statistical significance, vitamin C may be a useful supplement to iron in treating anemia.
Key facts
- Study ID
- NCT03564756
- Run by
- Fetal Medicine Foundation
- People needed
- 0
- Starts
- 2019-08-01
- Expected to finish
- 2022-03-30
- Last updated by the study team
- 2022-09-22
Who can join
Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- gestational age at enrollment less than 20 0/7 weeks,
- singleton gestation,
- iron deficiency anemia defined as maternal serum ferritin levels less than 15 micrograms/dL, and
- planned delivery at Miami Valley Hospital.
You may not qualify if…
- vitamin C use >150mg/day (typical prenatal vitamin contains 60mg Vitamin C),
- diabetes (gestational, types 1,2); chronic medical disease;
- known or discovered hemoglobinopathy (including heterozygous states);
- known metabolic disease that may contribute to impaired iron absorption (including a history of bariatric surgery, renal disease and an inability to tolerate oral iron);
- known fetal abnormalities;
- participation in another interventional trial;
- illicit drug or alcohol use
Where it is running
- Five Rivers Health Centers — Dayton, Ohio, United States
Full record on ClinicalTrials.gov
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