Vitamin B12 Pregnancy Supplementation

Study Overview
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Brief Summary
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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.

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

Conditions
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Pregnancy Anemia

Intervention / Treatment
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* Dietary Supplement: vitamin b12


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy women from 8th week of pregnancy Exclusion Criteria: existence of hypertension existence of diabetes existence of genetic abnormalities smoking previous miscarriage

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized clinical trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Receiving treatment<br>Adding vitamin B12 at a dose of 5 μg / 100 days, custom folic acid therapy and iron supplements | Dietary Supplement: vitamin b12<br>* Vitamin B12 has been added to the experimental group of pregnant women, at a dose of 5 μg / 100 days<br>|
| No Intervention: Control group<br>Standard prenatal care (custom folic acid therapy and iron supplements) | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vitamin b12, pregnancy, anemia