A randomized controlled trial examining the addition of folic acid to iron supplementation in the treatment of postpartum anemia.
OBJECTIVE
To evaluate the efficacy of adding folic acid to oral iron supplementation in postpartum women with anemia.


METHODS
A randomized controlled trial was conducted in the Netherlands between April 8, 2008, and August 31, 2010. A total of 112 postpartum women with anemia (hemoglobin <10.5 g/dL) were randomly allocated to receive 600 mg/day ferrous fumarate plus 1mg/day folic acid (FFFA group) or 600/day ferrous fumarate alone (FF group) for 4 weeks. Primary outcome measures were hemoglobin and health status. Secondary outcome measures were fatigue, compliance, and adverse reactions.


RESULTS
No between-group differences were observed in hemoglobin and health status after treatment, and no differences were found in fatigue scores. Approximately 75% of all women reported having at least one symptom resulting from ferrous fumarate use. Constipation caused by ferrous fumarate was significantly associated with non-compliance (P=0.014).


CONCLUSIONS
The addition of folic acid to iron supplementation is not beneficial in women with postpartum anemia, as it has no effect on hematologic or health status parameters.


BACKGROUND
CCMO website NL21797.028.08 and Netherlands Trial Register NTR2232.
CoRPS, Department of Medical and Clinical Psychology, Tilburg University, Tilburg, The Netherlands; Department of Gynecology and Obstetrics, TweeSteden Hospital, Tilburg, The Netherlands. Electronic address: daisyvanderwoude@hotmail.com.
Daisy A A
DA
Van Der Woude
CoRPS, Department of Medical and Clinical Psychology, Tilburg University, Tilburg, The Netherlands; Department of Medical Psychology, St Elisabeth Hospital, Tilburg, The Netherlands.
Jolanda
J
De Vries
Department of Clinical Chemistry, Elisabeth Hospital and TweeSteden Hospital, Tilburg, The Netherlands.
Eduard M
EM
Van Wijk
Hospital Pharmacy, TweeSteden Hospital, Tilburg, The Netherlands.
Jacques M
JM
Verzijl
Department of Gynecology and Obstetrics, TweeSteden Hospital, Tilburg, The Netherlands.
Johanna M A
JM
Pijnenborg
D000328:Adult; D000740:Anemia / Q000097:blood / Q000188:drug therapy*; D019587:Dietary Supplements; D004359:Drug Therapy, Combination; D005260:Female; D005296:Ferrous Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D005492:Folic Acid / Q000097:blood / Q000627:therapeutic use*; D006304:Health Status; D006454:Hemoglobins / Q000032:analysis; D006801:Humans; D057194:Intention to Treat Analysis; D011644:Puerperal Disorders / Q000097:blood / Q000188:drug therapy*; D011795:Surveys and Questionnaires
D005296:Ferrous Compounds; D006454:Hemoglobins; D005492:Folic Acid; C031621:ferrous fumarate
Anemia; Compliance; Fatigue; Folic acid; Health status; Hemoglobin; Iron; Postpartum