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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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03522428
Enrollment
200
Registered
2018-05-11
Start date
2011-09-15
Completion date
2012-12-23
Last updated
2018-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy Anemia

Keywords

vitamin b12, pregnancy, anemia

Brief summary

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.

Interventions

DIETARY_SUPPLEMENTvitamin b12

Vitamin B12 has been added to the experimental group of pregnant women, at a dose of 5 μg / 100 days

Sponsors

Mirela Zec
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Caregiver)

Intervention model description

randomized clinical trial

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* healthy women from 8th week of pregnancy

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Change of Unsaturated Iron Binding Capacity (UIBC) in first and second trimesterat two time points: on the 8th-10th and 22nd-24th weeks of pregnancyunsaturated iron binding capacity in SI units (µmol/L)
Change of Hematocrit in first and second trimesterat two time points: on the 8th-10th and 22nd-24th weeks of pregnancyvolume percentage (%)
Change of Mean corpuscular volume (MCV) in first and second trimesterat two time points: on the 8th-10th and 22nd-24th weeks of pregnancymean volume of red blood cells in SI units (fL)
Change of Mean corpuscular hemoglobin concentration (MCHC) in first and second trimesterat two time points: on the 8th-10th and 22nd-24th weeks of pregnancyAverage hemoglobin concentration in a given volume of packed RBCs i SI units (g/L)
Change of Mean corpuscular hemoglobin (MCH) in first and second trimesterat two time points: on the 8th-10th and 22nd-24th weeks of pregnancyaverage weight of hemoglobin in an average red blood cell in SI units (pg)
Change of Iron (Fe) in first and second trimesterat two time points: on the 8th-10th and 22nd-24th weeks of pregnancynon-heme iron in serum in SI units (µmol/L)
Change of Haptoglobin in first and second trimesterat two time points: on the 8th-10th and 22nd-24th weeks of pregnancyconcentration of free haptoglobin in serum in SI units (g/L)
Change of Ferritin in first and second trimesterat two time points: on the 8th-10th and 22nd-24th weeks of pregnancyserum ferritin in SI units (µg/L)
Change of Total Iron Binding Capacity (TIBC) in first and second trimesterat two time points: on the 8th-10th and 22nd-24th weeks of pregnancytotal iron binding capacity in SI units (µmol/L)
Change of Red blood cells (RBC) count in first and second trimesterat two time points: on the 8th-10th and 22nd-24th weeks of pregnancyRBC count measured in SI (Systeme International) units (Nx10\*12/L)
Change of Hemoglobin (Hgb) concentration in first and second trimesterat two time points: on the 8th-10th and 22nd-24th weeks of pregnancyHgb concentration in SI units (g/L)

Secondary

MeasureTime frameDescription
Change of Platelet Count in first and second trimesterat two time points: on the 8th-10th and 22nd-24th weeks of pregnancyRBC count measured in SI units (Nx10\*9/L)
Change of Transferrin in first and second trimesterat two time points: on the 8th-10th and 22nd-24th weeks of pregnancytransferrin serum concentration in SI units (g/L)
Change of Neutrophils in first and second trimesterat two time points: on the 8th-10th and 22nd-24th weeks of pregnancyproportion of neutrophils of all white cells (%)
Change of Lymphocytes in first and second trimesterat two time points: on the 8th-10th and 22nd-24th weeks of pregnancyproportion of lymphocytes of all white cells (%)
Change of Monocytes in first and second trimesterat two time points: on the 8th-10th and 22nd-24th weeks of pregnancyproportion of monocytes of all white cells (%)
Change of Eosinophils in first and second trimesterat two time points: on the 8th-10th and 22nd-24th weeks of pregnancyproportion of eosinophils of all white cells (%)
Change of Basophils in first and second trimesterat two time points: on the 8th-10th and 22nd-24th weeks of pregnancyproportion of basophils of all white cells (%)
Change of White Blood Cells (WBC) in first and second trimesterat two time points: on the 8th-10th and 22nd-24th weeks of pregnancyRBC count measured in SI units (Nx10\*9/L)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026