PMID- 35276810
OWN - NLM
STAT- MEDLINE
DCOM- 20220315
LR  - 20230308
IS  - 2072-6643 (Electronic)
IS  - 2072-6643 (Linking)
VI  - 14
IP  - 3
DP  - 2022 Jan 20
TI  - Efficacy and Safety of Ferrous Bisglycinate and Folinic Acid in the Control of 
      Iron Deficiency in Pregnant Women: A Randomized, Controlled Trial.
LID - 10.3390/nu14030452 [doi]
LID - 452
AB  - Iron deficiency in pregnancy is a major public health problem that causes 
      maternal complications. The objective of this randomized, controlled trial was to 
      examine the bioavailability, efficacy, and safety of oral ferrous bisglycinate 
      plus folinic acid supplementation in pregnant women with iron deficiency. 
      Subjects (12-16 weeks of gestation, n = 120) were randomly allocated to receive 
      oral iron as ferrous bisglycinate (equiv. iron 24 mg) in supplement form with 
      folinic acid and multivitamins (test group, n = 60) or as ferrous fumarate 
      (equiv. iron 66 mg iron, control group, n = 60) after breakfast daily. Iron 
      absorption was assessed by measuring fasted serum iron levels at 1 and 2 h 
      immediately after supplementation. Hematological biomarkers and iron status were 
      assessed before intervention, and at 3 and 6 months. Side effects were monitored 
      throughout the intervention. A significant increase in serum iron was seen in 
      both groups (p < 0.001) during the bioavailability assessment; however, the test 
      group increases were comparatively higher than the control values at each 
      timepoint (p < 0.001). Similarly, both test and control groups demonstrated a 
      statistically significant increases in hemoglobin (Hb) (p < 0.001), erythrocytes 
      (p < 0.001), reticulocytes (p < 0.001), mean corpuscular volume (MCV) (p < 
      0.001), mean corpuscular hemoglobin (MCH) (p < 0.001), mean corpuscular 
      hemoglobin concentration (MCHC) (p < 0.001), % transferrin saturation (p < 
      0.001), and ferritin (p < 0.001) at 3 and 6 months after supplementation. 
      However, in all cases, the test group increases were numerically larger than the 
      control group increases at each timepoint. The test intervention was also 
      associated with significantly fewer reports of nausea, abdominal pain, bloating, 
      constipation, or metallic taste (p < 0.001). In conclusion, ferrous bisglycinate 
      with folinic acid as a multivitamin nutraceutical format is comparable to 
      standard ferrous fumarate for the clinical management of iron deficiency during 
      pregnancy, with comparatively better absorption, tolerability, and efficacy and 
      with a lower elemental iron dosage.
FAU - Bumrungpert, Akkarach
AU  - Bumrungpert A
AUID- ORCID: 0000-0001-6893-6006
AD  - Research Center of Nutraceuticals and Natural Products for Health & Anti-Aging, 
      College of Integrative Medicine, Dhurakij Pundit University, Bangkok 10210, 
      Thailand.
FAU - Pavadhgul, Patcharanee
AU  - Pavadhgul P
AUID- ORCID: 0000-0001-9514-9622
AD  - Department of Nutrition, Faculty of Public Health, Mahidol University, Bangkok 
      10400, Thailand.
FAU - Piromsawasdi, Theera
AU  - Piromsawasdi T
AD  - Health Promotion Hospital, Health Center Region 5, Ratchaburi 70000, Thailand.
FAU - Mozafari, M R
AU  - Mozafari MR
AUID- ORCID: 0000-0002-4118-1544
AD  - Australasian Nanoscience and Nanotechnology Initiative (ANNI), Monash University 
      LPO, Clayton, VIC 3168, Australia.
LA  - eng
GR  - n/a/This research was funded by Max Biocare Pty Ltd, Australia./
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20220120
PL  - Switzerland
TA  - Nutrients
JT  - Nutrients
JID - 101521595
RN  - 0 (Biomarkers)
RN  - 0 (Ferrous Compounds)
RN  - Q573I9DVLP (Leucovorin)
RN  - R5L488RY0Q (ferrous fumarate)
RN  - SFW1D987QV (ferrous bisglycinate)
RN  - TE7660XO1C (Glycine)
SB  - IM
MH  - *Anemia, Iron-Deficiency/blood/drug therapy
MH  - Biomarkers/blood
MH  - Female
MH  - *Ferrous Compounds/therapeutic use
MH  - Glycine/therapeutic use
MH  - Humans
MH  - *Iron Deficiencies/blood/drug therapy
MH  - Leucovorin/therapeutic use
MH  - Pregnancy
MH  - *Pregnancy Complications/blood/drug therapy
PMC - PMC8839493
OTO - NOTNLM
OT  - absorption
OT  - ferrous bisglycinate
OT  - folinic acid
OT  - iron deficiency
OT  - iron status
OT  - pregnant women
OT  - side effects
COIS- The authors declare no conflict of interest.
EDAT- 2022/03/13 06:00
MHDA- 2022/03/16 06:00
PMCR- 2022/01/20
CRDT- 2022/03/12 01:00
PHST- 2021/12/06 00:00 [received]
PHST- 2022/01/15 00:00 [revised]
PHST- 2022/01/18 00:00 [accepted]
PHST- 2022/03/12 01:00 [entrez]
PHST- 2022/03/13 06:00 [pubmed]
PHST- 2022/03/16 06:00 [medline]
PHST- 2022/01/20 00:00 [pmc-release]
AID - nu14030452 [pii]
AID - nutrients-14-00452 [pii]
AID - 10.3390/nu14030452 [doi]
PST - epublish
SO  - Nutrients. 2022 Jan 20;14(3):452. doi: 10.3390/nu14030452.