Vitamin B12 Pregnancy Supplementation

May 10, 2018 updated by: Mirela Zec

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • healthy women from 8th week of pregnancy

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: Receiving treatment
Adding vitamin B12 at a dose of 5 μg / 100 days, custom folic acid therapy and iron supplements
Dietary supplement: vitamin b12
Vitamin B12 has been added to the experimental group of pregnant women, at a dose of 5 μg / 100 days
NO_INTERVENTION: Control group
Standard prenatal care (custom folic acid therapy and iron supplements)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change of Red blood cells (RBC) count in first and second trimester
Time Frame: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
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
Time Frame: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
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
Time Frame: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
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
Time Frame: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
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
Time Frame: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
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
Time Frame: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
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
Time Frame: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
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
Time Frame: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
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
Time Frame: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
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
Time Frame: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
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
Time Frame: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change of White Blood Cells (WBC) in first and second trimester
Time Frame: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
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
Time Frame: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
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
Time Frame: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
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
Time Frame: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
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
Time Frame: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
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
Time Frame: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
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
Time Frame: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
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
Time Frame: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
proportion of basophils of all white cells (%)
at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mirela Zec

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Damir Roje, Prof., Clinical Hospital Center, Split

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 23, 2012

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 23, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 6, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 11, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • dupin

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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