Clinical trial NCT03522428: Vitamin B12 Pregnancy Supplementation
Official title: Vitamin B12 Supplementation in Addition to Folic Acid and Iron Improves Hematological and Biochemical Markers in Pregnancy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pregnancy Anemia
Keywords: vitamin b12
pregnancy
anemia
Lead sponsor: University of Split, School of Medicine
Sponsor class: OTHER
First posted: 2018-05-11
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized clinical trial
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* healthy women from 8th week of pregnancy

Exclusion Criteria:

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

Primary outcomes:
measure: Change of Red blood cells (RBC) count in first and second trimester
timeFrame: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
measure: Change of Hemoglobin (Hgb) concentration in first and second trimester
timeFrame: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
measure: Change of Hematocrit in first and second trimester
timeFrame: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
measure: Change of Mean corpuscular volume (MCV) in first and second trimester
timeFrame: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
measure: Change of Mean corpuscular hemoglobin concentration (MCHC) in first and second trimester
timeFrame: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
measure: Change of Mean corpuscular hemoglobin (MCH) in first and second trimester
timeFrame: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
measure: Change of Iron (Fe) in first and second trimester
timeFrame: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
measure: Change of Haptoglobin in first and second trimester
timeFrame: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
measure: Change of Ferritin in first and second trimester
timeFrame: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
measure: Change of Total Iron Binding Capacity (TIBC) in first and second trimester
timeFrame: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
measure: Change of Unsaturated Iron Binding Capacity (UIBC) in first and second trimester
timeFrame: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
Secondary outcomes:
measure: Change of White Blood Cells (WBC) in first and second trimester
timeFrame: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
measure: Change of Platelet Count in first and second trimester
timeFrame: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
measure: Change of Transferrin in first and second trimester
timeFrame: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
measure: Change of Neutrophils in first and second trimester
timeFrame: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
measure: Change of Lymphocytes in first and second trimester
timeFrame: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
measure: Change of Monocytes in first and second trimester
timeFrame: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
measure: Change of Eosinophils in first and second trimester
timeFrame: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
measure: Change of Basophils in first and second trimester
timeFrame: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
Other outcomes:
Locations:
Study officials:
affiliation: Clinical Hospital Center, Split
name: Damir Roje, Prof.
role: STUDY_DIRECTOR
References: