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Vitamin B12 Pregnancy Supplementation

Primary Purpose

Pregnancy Anemia

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

vitamin b12

About this trial

This is an interventional prevention trial for Pregnancy Anemia focused on measuring vitamin b12, pregnancy, anemia

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Receiving treatment

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

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

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

Hgb concentration in SI units (g/L)

Change of Hematocrit in first and second trimester

volume percentage (%)

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

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

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)

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)

Change of Iron (Fe) in first and second trimester

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

Change of Haptoglobin in first and second trimester

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

Change of Ferritin in first and second trimester

serum ferritin in SI units (µg/L)

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

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

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

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

Secondary Outcome Measures

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

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

Change of Platelet Count in first and second trimester

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

Change of Transferrin in first and second trimester

transferrin serum concentration in SI units (g/L)

Change of Neutrophils in first and second trimester

proportion of neutrophils of all white cells (%)

Change of Lymphocytes in first and second trimester

proportion of lymphocytes of all white cells (%)

Change of Monocytes in first and second trimester

proportion of monocytes of all white cells (%)

Change of Eosinophils in first and second trimester

proportion of eosinophils of all white cells (%)

Change of Basophils in first and second trimester

proportion of basophils of all white cells (%)

Full Information

NCT ID

NCT03522428

First Posted

April 6, 2018

Last Updated

May 10, 2018

Sponsor

Mirela Zec

1. Study Identification

Unique Protocol Identification Number

NCT03522428

Brief Title

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

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Completed

Study Start Date

September 15, 2011 (Actual)

Primary Completion Date

December 23, 2012 (Actual)

Study Completion Date

December 23, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Mirela Zec

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pregnancy Anemia

Keywords

vitamin b12, pregnancy, anemia

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

randomized clinical trial

Masking

Care Provider

Allocation

Randomized

Enrollment

200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Receiving treatment

Arm Type

Active Comparator

Arm Description

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

Arm Title

Control group

Arm Type

No Intervention

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

vitamin b12

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

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

Title

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

Description

Hgb concentration in SI units (g/L)

Time Frame

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

Title

Change of Hematocrit in first and second trimester

Description

volume percentage (%)

Time Frame

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

Title

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

Description

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

Time Frame

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

Title

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

Description

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

Time Frame

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

Title

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

Description

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

Time Frame

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

Title

Change of Iron (Fe) in first and second trimester

Description

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

Time Frame

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

Title

Change of Haptoglobin in first and second trimester

Description

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

Time Frame

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

Title

Change of Ferritin in first and second trimester

Description

serum ferritin in SI units (µg/L)

Time Frame

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

Title

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

Description

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

Time Frame

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

Title

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

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

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

Description

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

Time Frame

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

Title

Change of Platelet Count in first and second trimester

Description

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

Time Frame

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

Title

Change of Transferrin in first and second trimester

Description

transferrin serum concentration in SI units (g/L)

Time Frame

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

Title

Change of Neutrophils in first and second trimester

Description

proportion of neutrophils of all white cells (%)

Time Frame

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

Title

Change of Lymphocytes in first and second trimester

Description

proportion of lymphocytes of all white cells (%)

Time Frame

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

Title

Change of Monocytes in first and second trimester

Description

proportion of monocytes of all white cells (%)

Time Frame

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

Title

Change of Eosinophils in first and second trimester

Description

proportion of eosinophils of all white cells (%)

Time Frame

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

Title

Change of Basophils in first and second trimester

Description

proportion of basophils of all white cells (%)

Time Frame

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Damir Roje, Prof.

Organizational Affiliation

Clinical Hospital Center, Split

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

Vitamin B12 Pregnancy Supplementation

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