Vitamin B12 Pregnancy Supplementation

• Sponsor: Mirela Zec (Other)
• Overall Status: Completed
• CT.gov ID: NCT03522428
• Collaborator: (none)
• Enrollment: 200
• Arms: 2
• Actual Duration (Months): 15.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy Anemia	Dietary Supplement: vitamin b12	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: randomized clinical trialrandomized 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: Sep 15, 2011
• Actual Primary Completion Date: Dec 23, 2012
• Actual Study Completion Date: Dec 23, 2012

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. Change of Red blood cells (RBC) count in first and second trimester [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy]

   proportion of basophils of all white cells (%)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• healthy women from 8th week of pregnancy

Exclusion Criteria:

• existence of hypertension

• existence of diabetes

• existence of genetic abnormalities

• smoking

• previous miscarriage

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Mirela Zec

Investigators

• Study Director: Damir Roje, Prof., Clinical Hospital Center, Split

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mirela Zec, master of laboratory medicine diagnostics, University of Split, School of Medicine
• ClinicalTrials.gov Identifier: NCT03522428
• Other Study ID Numbers: dupin
• First Posted: May 11, 2018
• Last Update Posted: May 11, 2018
• Last Verified: May 1, 2018

• 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, master of laboratory medicine diagnostics, University of Split, School of Medicine: vitamin b12; pregnancy; anemia
• Additional relevant MeSH terms: Anemia; Vitamin B 12; Hydroxocobalamin

Study Results

No Results Posted as of May 11, 2018