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Vitamin B12 Pregnancy Supplementation

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ClinicalTrials.gov Identifier: NCT03522428
Recruitment Status : Completed
First Posted : May 11, 2018
Last Update Posted : May 11, 2018
Sponsor:
Information provided by (Responsible Party):
Mirela Zec, University of Split, School of Medicine

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.


Condition or disease Intervention/treatment Phase
Pregnancy Anemia Dietary Supplement: vitamin b12 Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized clinical trial
Masking: Single (Care Provider)
Primary Purpose: Prevention
Official Title: Vitamin B12 Supplementation in Addition to Folic Acid and Iron Improves Hematological and Biochemical Markers in Pregnancy: a Randomized Controlled Trial
Actual Study Start Date : September 15, 2011
Actual Primary Completion Date : December 23, 2012
Actual Study Completion Date : December 23, 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)



Primary Outcome Measures :
  1. 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)

  2. 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)

  3. 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 (%)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. 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)


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)

  4. 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 (%)

  5. 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 (%)

  6. 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 (%)

  7. 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 (%)

  8. 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 (%)



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03522428


Sponsors and Collaborators
Mirela Zec
Investigators
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Study Director: Damir Roje, Prof. Clinical Hospital Center, Split

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Responsible Party: Mirela Zec, master of laboratory medicine diagnostics, University of Split, School of Medicine
ClinicalTrials.gov Identifier: NCT03522428     History of Changes
Other Study ID Numbers: dupin
First Posted: May 11, 2018    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: May 2018

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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
Keywords provided by Mirela Zec, University of Split, School of Medicine:
vitamin b12
pregnancy
anemia
Additional relevant MeSH terms:
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Anemia
Hematologic Diseases
Vitamins
Folic Acid
Hydroxocobalamin
Vitamin B 12
Vitamin B Complex
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Hematinics