Vitamin B12 Pregnancy Supplementation

Mirela Zec

Status and phase: Completed; Phase 4

Conditions: Pregnancy Anemia

Treatments: Dietary Supplement: vitamin b12

Study type: Interventional

Funder types: Other

Identifiers

NCT03522428

dupin

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy women from 8th week of pregnancy

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Receiving treatment

Active Comparator group

Description:

Adding vitamin B12 at a dose of 5 μg / 100 days, custom folic acid therapy and iron supplements

Treatment:

Dietary Supplement: vitamin b12

Control group

No Intervention group

Description:

Standard prenatal care (custom folic acid therapy and iron supplements)