title: Comparative effectiveness of a prenatal medical food to prenatal vitamins on hemoglobin levels and adverse outcomes: a retrospective analysis.
abstract: BACKGROUND
  The role of folate in pregnancy is well established, with most prenatal vitamins (PNVs) on the market containing at least 800 μg of folic acid. Folic acid must be converted in the body to L-methylfolate, the natural and biologically active form of folate. The role of vitamin B(12) in pregnancy is less characterized, and most PNV formulations contain only 0 to 12 μg. The present study was undertaken to evaluate whether taking a prenatal medical food containing L-methylfolate and much higher doses of vitamin B(12) results in higher hemoglobin levels and thus, a lower incidence of anemia during pregnancy.
  
  
  OBJECTIVE
  The objective of this exploratory study was to evaluate the effects of the prenatal medical food versus standard PNVs on hemoglobin levels and adverse outcomes throughout pregnancy.
  
  
  METHODS
  For this retrospective analysis, we reviewed the charts of female patients taking either a prenatal medical food or standard PNV during pregnancy. Hemoglobin levels measured at initiation of prenatal care, end of second trimester, and delivery were recorded. Patients who had received additional iron supplementation, beyond that contained in the prenatal medical food or PNV they were taking and before anemia screening at the end of the second trimester, were excluded from the study. Fisher exact test, χ(2) test, student t test, and ANOVA were used to evaluate differences between the treatment groups.
  
  
  RESULTS
  Data were analyzed from 112 charts: 58 patients (51.8%) were taking the prenatal medical food; 54 patients (48.2%) were taking standard PNVs. Mean (SD) age at first prenatal visit was 27 (4.6) years in the medical food group and 28.8 (3.5) years in the PNV group (P = 0.024). Mean (SD) body mass indices were 29.1 (6.5) and 31.7 (8.9) in the medical food and PNV groups, respectively (P = NS). In the medical food group, 35 women (60.3%) were white/Caucasian, 17 (29.3%) were African American, and 6 (10.4%) were of other races. In the PNV group, 24 women (44.4%) were white/Caucasian, 25 (46.3%) were African American, and 5 (9.3%) were of other races. However, race was not significantly different between the two groups. At end of second trimester and at delivery, mean (SD) hemoglobin levels were higher in the prenatal medical food group (11.8 [1.1] g/dL and 11.8 [1.3] g/dL, respectively) than in the PNV group (11.3 [1.2] g/dL and 10.7 [1.2] g/dL, respectively) (P = 0.011 and P = 0.001, respectively). Significantly fewer cases of anemia were reported at end of second trimester in the prenatal medical food group than in the PNV group (39.7% vs 74.1%; P = 0.001).
  
  
  CONCLUSIONS
  In the present study, supplementation with a prenatal medical food containing L-methylfolate and high-dose vitamin B(12) may maintain hemoglobin levels and decrease rates of anemia in pregnancy more effectively than standard prenatal vitamins; however, prospective, controlled studies are warranted. ClinicalTrials.gov identifier: NCT01193192.
authors: Women's Clinic Shoals, Sheffield, Alabama 35660, USA. subent@bellsouth.net
authors: Susan
authors: S
authors: Bentley
authors: Amy
authors: A
authors: Hermes
authors: Diane
authors: D
authors: Phillips
authors: Yahya A
authors: YA
authors: Daoud
authors: Sylvia
authors: S
authors: Hanna
mesh_terms: D000328:Adult; D000740:Anemia / Q000097:blood / Q000453:epidemiology / Q000517:prevention & control; D002986:Clinical Trials as Topic; D004281:Docosahexaenoic Acids / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005492:Folic Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005527:Food, Fortified / Q000009:adverse effects; D006454:Hemoglobins / Q000032:analysis*; D006801:Humans; D015994:Incidence; D011225:Pre-Eclampsia / Q000097:blood / Q000453:epidemiology / Q000517:prevention & control; D011247:Pregnancy; D011250:Pregnancy Complications, Hematologic / Q000097:blood / Q000453:epidemiology / Q000517:prevention & control; D011256:Pregnancy Outcome; D011262:Pregnancy Trimester, Second; D011295:Prenatal Care; D012189:Retrospective Studies; D014805:Vitamin B 12 / Q000008:administration & dosage / Q000627:therapeutic use*; D014815:Vitamins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D006454:Hemoglobins; D014815:Vitamins; D004281:Docosahexaenoic Acids; D005492:Folic Acid; D014805:Vitamin B 12