Vitamin B12 Pregnancy Supplementation

NCT ID: NCT03522428

Last Updated: 2018-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-15
• Study Completion Date: 2012-12-23

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.

Conditions

Pregnancy Anemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Receiving treatment

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

Group Type: ACTIVE_COMPARATOR

vitamin b12

Intervention Type: DIETARY_SUPPLEMENT

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

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

vitamin b12

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

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Mirela Zec

OTHER

Sponsor Role: lead

Responsible Party

Mirela Zec

master of laboratory medicine diagnostics

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Damir Roje, Prof.

Role: STUDY_DIRECTOR

Clinical Hospital Center, Split

Other Identifiers

dupin

Identifier Type: -

Identifier Source: org_study_id