Defining the plasma folate concentration associated with the red blood cell folate concentration threshold for optimal neural tube defects prevention: a population-based, randomized trial of folic acid supplementation

Am J Clin Nutr. 2019 May 1;109(5):1452-1461. doi: 10.1093/ajcn/nqz027.

Abstract

Background: For women of reproductive age, a population-level red blood cell (RBC) folate concentration below the threshold 906 nmol/L or 400 ng/mL indicates folate insufficiency and suboptimal neural tube defect (NTD) prevention. A corresponding population plasma/serum folate concentration threshold for optimal NTD prevention has not been established.

Objective: The aim of this study was to examine the association between plasma and RBC folate concentrations and estimated a population plasma folate insufficiency threshold (pf-IT) corresponding to the RBC folate insufficiency threshold (RBCf-IT) of 906 nmol/L.

Methods: We analyzed data on women of reproductive age (n = 1673) who participated in a population-based, randomized folic acid supplementation trial in northern China. Of these women, 565 women with anemia and/or vitamin B-12 deficiency were ineligible for folic acid intervention (nonintervention group); the other 1108 received folic acid supplementation for 6 mo (intervention group). We developed a Bayesian linear model to estimate the pf-IT corresponding to RBCf-IT by time from supplementation initiation, folic acid dosage, methyltetrahydrofolate reductase (MTHFR) genotype, body mass index (BMI), vitamin B-12 status, or anemia status.

Results: Using plasma and RBC folate concentrations of the intervention group, the estimated median pf-IT was 25.5 nmol/L (95% credible interval: 24.6, 26.4). The median pf-ITs were similar between the baseline and postsupplementation samples (25.7 compared with 25.2 nmol/L) but differed moderately (±3-4 nmol/L) by MTHFR genotype and BMI. Using the full population-based baseline sample (intervention and nonintervention), the median pf-IT was higher for women with vitamin B-12 deficiency (34.6 nmol/L) and marginal deficiency (29.8 nmol/L) compared with the sufficient group (25.6 nmol/L).

Conclusions: The relation between RBC and plasma folate concentrations was modified by BMI and genotype and substantially by low plasma vitamin B-12. This suggests that the threshold of 25.5 nmol/L for optimal NTD prevention may be appropriate in populations with similar characteristics, but it should not be used in vitamin B-12 insufficient populations. This trial was registered at clinicaltrials.gov as NCT00207558.

Keywords: Bayesian; folic acid; neural tube defects; plasma folate; red blood cell folate; vitamin B-12.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Bayes Theorem
  • Body Mass Index
  • China
  • Dietary Supplements*
  • Erythrocytes / metabolism*
  • Female
  • Folic Acid / blood
  • Folic Acid / therapeutic use*
  • Folic Acid Deficiency / blood
  • Folic Acid Deficiency / diagnosis*
  • Folic Acid Deficiency / drug therapy
  • Genotype
  • Humans
  • Methylenetetrahydrofolate Reductase (NADPH2) / genetics
  • Neural Tube Defects / prevention & control*
  • Nutrition Therapy
  • Population Health
  • Preconception Care / methods*
  • Preconception Care / standards
  • Pregnancy
  • Reference Values
  • Vitamin B 12 / blood*
  • Vitamin B 12 Deficiency / blood
  • Young Adult

Substances

  • Folic Acid
  • MTHFR protein, human
  • Methylenetetrahydrofolate Reductase (NADPH2)
  • Vitamin B 12

Associated data

  • ClinicalTrials.gov/NCT00207558