Skip to main content
OpenTrials
Completed

NCT Number: NCT03522428

Vitamin B12 Pregnancy Supplementation

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy women from 8th week of pregnancy

Exclusion criteria

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

Treatment and study plan

Vitamin B12

Dietary Supplement

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

Primary outcomes

  1. Change of Red blood cells (RBC) count in first and second trimester

    Time frame: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy

    RBC count measured in SI (Systeme International) units (Nx10*12/L)

  2. Change of Hemoglobin (Hgb) concentration in first and second trimester

    Time frame: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy

    Hgb concentration in SI units (g/L)

  3. Change of Hematocrit in first and second trimester

    Time frame: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy

    volume percentage (%)

  4. Change of Mean corpuscular volume (MCV) in first and second trimester

    Time frame: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy

    mean volume of red blood cells in SI units (fL)

  5. Change of Mean corpuscular hemoglobin concentration (MCHC) in first and second trimester

    Time frame: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy

    Average hemoglobin concentration in a given volume of packed RBCs i SI units (g/L)

  6. Change of Mean corpuscular hemoglobin (MCH) in first and second trimester

    Time frame: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy

    average weight of hemoglobin in an average red blood cell in SI units (pg)

  7. Change of Iron (Fe) in first and second trimester

    Time frame: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy

    non-heme iron in serum in SI units (µmol/L)

  8. Change of Haptoglobin in first and second trimester

    Time frame: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy

    concentration of free haptoglobin in serum in SI units (g/L)

  9. Change of Ferritin in first and second trimester

    Time frame: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy

    serum ferritin in SI units (µg/L)

  10. Change of Total Iron Binding Capacity (TIBC) in first and second trimester

    Time frame: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy

    total iron binding capacity in SI units (µmol/L)

  11. Change of Unsaturated Iron Binding Capacity (UIBC) in first and second trimester

    Time frame: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy

    unsaturated iron binding capacity in SI units (µmol/L)

Secondary outcomes

  1. Change of White Blood Cells (WBC) in first and second trimester

    Time frame: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy

    RBC count measured in SI units (Nx10*9/L)

  2. Change of Platelet Count in first and second trimester

    Time frame: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy

    RBC count measured in SI units (Nx10*9/L)

  3. Change of Transferrin in first and second trimester

    Time frame: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy

    transferrin serum concentration in SI units (g/L)

  4. Change of Neutrophils in first and second trimester

    Time frame: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy

    proportion of neutrophils of all white cells (%)

  5. Change of Lymphocytes in first and second trimester

    Time frame: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy

    proportion of lymphocytes of all white cells (%)

  6. Change of Monocytes in first and second trimester

    Time frame: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy

    proportion of monocytes of all white cells (%)

  7. Change of Eosinophils in first and second trimester

    Time frame: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy

    proportion of eosinophils of all white cells (%)

  8. Change of Basophils in first and second trimester

    Time frame: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy

    proportion of basophils of all white cells (%)

Sponsors and collaborators

Lead sponsor

Mirela Zec

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
May 11, 2018
Registry last updated
May 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.