Pregnancy AnemiaPhase 4NCT03522428
Vitamin B12 Pregnancy Supplementation
A Phase 4 study testing vitamin b12 in people with Pregnancy Anemia, run by Mirela Zec.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Anemia
- What is being tested?
- vitamin b12
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2011to 23 Dec 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy women from 8th week of pregnancy
Who cannot join
- existence of hypertension
- existence of diabetes
- existence of genetic abnormalities
- smoking
- previous miscarriage
About this study
Official title: 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.
- Conditions
- Pregnancy Anemia
- Being tested
- vitamin b12
- Keywords
- vitamin b12, pregnancy, anemia
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin b12Dietary supplement
Vitamin B12 has been added to the experimental group of pregnant women, at a dose of 5 μg / 100 days
| Study group | Role | What they receive |
|---|---|---|
| Receiving treatment | Active comparator | Adding vitamin B12 at a dose of 5 μg / 100 days, custom folic acid therapy and iron supplements Receives: Dietary Supplement: vitamin b12 |
| Control group | No intervention | Standard prenatal care (custom folic acid therapy and iron supplements) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Red blood cells (RBC) count in first and second trimester
RBC count measured in SI (Systeme International) units (Nx10*12/L)
Measured: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
Change of Hemoglobin (Hgb) concentration in first and second trimester
Hgb concentration in SI units (g/L)
Measured: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
Change of Hematocrit in first and second trimester
volume percentage (%)
Measured: 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
mean volume of red blood cells in SI units (fL)
Measured: 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
Average hemoglobin concentration in a given volume of packed RBCs i SI units (g/L)
Measured: 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
average weight of hemoglobin in an average red blood cell in SI units (pg)
Measured: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
Change of Iron (Fe) in first and second trimester
non-heme iron in serum in SI units (µmol/L)
Measured: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
Change of Haptoglobin in first and second trimester
concentration of free haptoglobin in serum in SI units (g/L)
Measured: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
Change of Ferritin in first and second trimester
serum ferritin in SI units (µg/L)
Measured: 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
total iron binding capacity in SI units (µmol/L)
Measured: 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
unsaturated iron binding capacity in SI units (µmol/L)
Measured: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
Secondary outcomes (8)
Change of White Blood Cells (WBC) in first and second trimester
RBC count measured in SI units (Nx10*9/L)
Measured: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
Change of Platelet Count in first and second trimester
RBC count measured in SI units (Nx10*9/L)
Measured: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
Change of Transferrin in first and second trimester
transferrin serum concentration in SI units (g/L)
Measured: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
Change of Neutrophils in first and second trimester
proportion of neutrophils of all white cells (%)
Measured: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
Change of Lymphocytes in first and second trimester
proportion of lymphocytes of all white cells (%)
Measured: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
Change of Monocytes in first and second trimester
proportion of monocytes of all white cells (%)
Measured: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
Change of Eosinophils in first and second trimester
proportion of eosinophils of all white cells (%)
Measured: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
Change of Basophils in first and second trimester
proportion of basophils of all white cells (%)
Measured: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start15 Sep 2011
- Primary completion23 Dec 2012
- Study completion23 Dec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized clinical trial
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mirela Zec
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mirela Zec, University of Split, School of Medicine
- Investigators
- Damir Roje, Prof., Study director, Clinical Hospital Center, Split
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03522428
- Sponsor's protocol ID
- dupin
- Status last verified
- May 2018
- First submitted
- 6 Apr 2018
- Last updated
- 11 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin B12 Supplementation in Addition to Folic Acid and Iron Improves Hematological and Biochemical Markers in Pregnancy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03522428
- Acronym / sponsor ID
- dupin
- Conditions
- Pregnancy Anemia
- Keywords
- vitamin b12, pregnancy, anemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Mirela ZecUniversity, hospital or other
- Study start
- 15 Sep 2011 (actual)
- Primary completion
- 23 Dec 2012 (actual)
- Study completion
- 23 Dec 2012 (actual)
- First posted
- 11 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Receiving treatment | Active comparator | Dietary Supplement: vitamin b12Adding vitamin B12 at a dose of 5 μg / 100 days, custom folic acid therapy and iron supplements |
| Control group | No intervention | –Standard prenatal care (custom folic acid therapy and iron supplements) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy women from 8th week of pregnancy
Key exclusion criteria (5 listed)
- existence of hypertension
- existence of diabetes
- existence of genetic abnormalities
- smoking
- previous miscarriage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vitamin b12Vitamin B12 has been added to the experimental group of pregnant women, at a dose of 5 μg / 100 days | Dietary supplement | Receiving treatment |
Primary outcome
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)
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)
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 (%)
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)
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)
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)
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)
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)
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)
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)
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)
8 secondary outcomes
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
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
Change of Transferrin in first and second trimester
Time frame: 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
Change of Lymphocytes in first and second trimester
Time frame: 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
Change of Eosinophils in first and second trimester
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Damir Roje, Prof. study director
Clinical Hospital Center, Split
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing vitamin b12 in people with Pregnancy Anemia, run by Mirela Zec.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2018.