Abstract
Consumption of 400 μg folic acid per day from fortified foods and/or supplements,
plus food folate from a varied diet is recommended for women of childbearing potential
to reduce the risk for neural tube defects during fetal development. This randomized
crossover study was designed to evaluate the bioavailability of folic acid from a
multivitamin softgel capsule vs a folic acid tablet in 16 premenopausal women (18
to 45 years of age). Participants were randomly assigned to receive a single dose
of ∼1,000 μg folic acid in two tablets or ∼1,000 μg folic acid in a multivitamin softgel
capsule, and then crossed over to receive the other study product ∼1 week later. Products
were administered with a low-folate breakfast. Blood samples were collected predose
(0 hour) and 1, 2, 3, 4, 6, and 8 hours post-dose for serum folate analysis. Repeated
measures analysis of variance was used to compare responses between treatments. Data
from the two sequence groups (n=8 per sequence) were pooled. Mean serum folate total
and net incremental areas under the curve (AUC0-8 hours) were not significantly different between tablets and softgel capsule (AUC0-8 hours 214.9±11.2 hours×ng/mL [487±25.4 hours×nmol/L] and 191.6±13.3 hours×ng/mL [434.2±30.1
hours×nmol/L]; net incremental AUC0-8 hours 117.3±8.5 hours×ng/mL [265.8±19.3 hours×nmol/L] and 105.8±12.5 hours×ng/mL [239.7±28.3
hours×nmol/L], respectively), nor was maximum folate concentration (45.1±2.5 ng/mL
[102.2±5.7 nmol/L] and 42.5±3.8 ng/mL [96.3±8.6 nmol/L], respectively). Time to peak
folate concentration was significantly (P<0.001) delayed for the softgel capsule vs tablet (3.9±0.3 vs 1.7±0.2 hours, respectively).
In conclusion, apparent bioavailability of folic acid was similar for the folic acid
tablets and a multivitamin softgel capsule.
Keywords
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Biography
K. C. Maki is president and chief science officer, Biofortis Clinical Research, Addison, IL.
Biography
K. M. Kelley is clinical investigator, Biofortis Clinical Research, Addison, IL.
Biography
A. L. Lawless is clinical investigator, Biofortis Clinical Research, Addison, IL.
Biography
J. M. Shields is project manager, Biofortis Clinical Research, Addison, IL.
Biography
M. R. Dicklin is associate director of medical writing, Biofortis Clinical Research, Addison, IL.
Biography
L. I. Ndife is director of medical and scientific affairs, Pharmavite, LLC, Northridge, CA.
Biography
J. R. Brooks is vice president, science and technology, Pharmavite, LLC, Northridge, CA.
Biography
S. B. Wright is a registered dietitian and nutrition education specialist, Pharmavite, LLC, Northridge, CA.
Article info
Publication history
Published online: May 11, 2012
Accepted:
February 24,
2012
Footnotes
STATEMENT OF POTENTIAL CONFLICT OF INTEREST K. C. Maki has received research funding and consulting/speaking fees from Pharmavite. A. L. Lawless and K. M. Kelley have received research funding from Pharmavite. J. R. Brooks, S. B. Wright, and L. I. Ndife are employees of Pharmavite. M. R. Dicklin and J. M. Shields have no conflicts of interest.
FUNDING/SUPPORT This study was funded by Pharmavite, LLC, Northridge, CA.
Identification
Copyright
© 2012 Academy of Nutrition and Dietetics. Published by Elsevier Inc. All rights reserved.
