Vitamin B12 Pregnancy Supplementation

Vitamin B12 Supplementation in Addition to Folic Acid and Iron Improves Hematological and Biochemical Markers in Pregnancy: a Randomized Controlled Trial

Pregnancy is associated with increased requirements for iron and increased blood volume of up to 40%. Because expansion in plasma volume is higher than the increase in the mass of red blood cells, there is a fall in hemoglobin concentration, which leads to physiological anemia, characterized with lower hemoglobin (Hb), hematocrit and red blood cells, but without changes in mean corpuscular volume (MCV). Anemia in pregnancy is defined with Hb values under 110 g/L in the first trimester and under 105 g/L in the second and third trimester.

Iron deficiency is thought to be the most common nutrient deficiency among pregnant women. Consequences of anemia include delayed fetal growth, premature delivery, intrauterine fetal death, postpartum depression and delayed psychomotor development of a child. It is known that in women that are not anemic daily iron supplementation of 27 mg/day is sufficient, which can be obtained from adequate nutrition or body supplies. Iron supplementation is pregnancy has been recommended by the WHO (World Health Organisation) since 1959, and this recommendation was confirmed by numerous professional associations. However, in women with anemia, or women subjected to particular dietary regimens with diminished quantity of iron, including vegetarian or vegan diet, required supplementation dosage is higher, and estimated in the literature to be 120 mg/day.

The aim of this study was to analyze whether adding vitamin B12 (5 µg /100 days), along with folic acid and iron as supplement in pregnant women who are not anemic and who need only iron supplementation, will result in improvements of hematological and biochemical markers.

Study Overview

• Status: Completed
• Conditions: Pregnancy Anemia
• Intervention / Treatment: Dietary supplement: vitamin b12

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• healthy women from 8th week of pregnancy

Exclusion Criteria:

• existence of hypertension
• existence of diabetes
• existence of genetic abnormalities
• smoking
• previous miscarriage

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Receiving treatment; Adding vitamin B12 at a dose of 5 μg / 100 days, custom folic acid therapy and iron supplements	Dietary supplement: vitamin b12; Vitamin B12 has been added to the experimental group of pregnant women, at a dose of 5 μg / 100 days
NO_INTERVENTION: Control group; Standard prenatal care (custom folic acid therapy and iron supplements)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Red blood cells (RBC) count in first and second trimester	RBC count measured in SI (Systeme International) units (Nx10*12/L)	at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
Change of Hemoglobin (Hgb) concentration in first and second trimester	Hgb concentration in SI units (g/L)	at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
Change of Hematocrit in first and second trimester	volume percentage (%)	at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
Change of Mean corpuscular volume (MCV) in first and second trimester	mean volume of red blood cells in SI units (fL)	at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
Change of Mean corpuscular hemoglobin concentration (MCHC) in first and second trimester	Average hemoglobin concentration in a given volume of packed RBCs i SI units (g/L)	at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
Change of Mean corpuscular hemoglobin (MCH) in first and second trimester	average weight of hemoglobin in an average red blood cell in SI units (pg)	at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
Change of Iron (Fe) in first and second trimester	non-heme iron in serum in SI units (µmol/L)	at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
Change of Haptoglobin in first and second trimester	concentration of free haptoglobin in serum in SI units (g/L)	at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
Change of Ferritin in first and second trimester	serum ferritin in SI units (µg/L)	at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
Change of Total Iron Binding Capacity (TIBC) in first and second trimester	total iron binding capacity in SI units (µmol/L)	at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
Change of Unsaturated Iron Binding Capacity (UIBC) in first and second trimester	unsaturated iron binding capacity in SI units (µmol/L)	at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of White Blood Cells (WBC) in first and second trimester	RBC count measured in SI units (Nx10*9/L)	at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
Change of Platelet Count in first and second trimester	RBC count measured in SI units (Nx10*9/L)	at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
Change of Transferrin in first and second trimester	transferrin serum concentration in SI units (g/L)	at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
Change of Neutrophils in first and second trimester	proportion of neutrophils of all white cells (%)	at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
Change of Lymphocytes in first and second trimester	proportion of lymphocytes of all white cells (%)	at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
Change of Monocytes in first and second trimester	proportion of monocytes of all white cells (%)	at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
Change of Eosinophils in first and second trimester	proportion of eosinophils of all white cells (%)	at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
Change of Basophils in first and second trimester	proportion of basophils of all white cells (%)	at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy

Collaborators and Investigators

• Sponsor: Mirela Zec
• Investigators: Study Director: Damir Roje, Prof., Clinical Hospital Center, Split

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 15, 2011
• Primary Completion (ACTUAL): December 23, 2012
• Study Completion (ACTUAL): December 23, 2012

Study Registration Dates

• First Submitted: April 6, 2018
• First Submitted That Met QC Criteria: May 10, 2018
• First Posted (ACTUAL): May 11, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 11, 2018
• Last Update Submitted That Met QC Criteria: May 10, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: anemia; pregnancy; vitamin b12
• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia; Physiological Effects of Drugs; Micronutrients; Vitamins; Vitamin B Complex; Hematinics; Vitamin B 12; Hydroxocobalamin
• Other Study ID Numbers: dupin

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No