Vitamin B12 Pregnancy Supplementation

NCT03522428 | Completed Phase 4

• 1 other identifier: dupin
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pregnancy Anemia

Keywords

vitamin b12; pregnancy; anemia

Outcome Measures

Primary Outcomes (11)

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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

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

  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

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

• Change of Platelet Count in first and second trimester

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

• Change of Transferrin in first and second trimester

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

• Change of Neutrophils in first and second trimester

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

• Change of Lymphocytes in first and second trimester

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

Study Arms (2)

Receiving treatment

ACTIVE COMPARATOR

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

Dietary Supplement: vitamin b12

Control group

NO INTERVENTION

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

Interventions

vitamin b12 DIETARY_SUPPLEMENT

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

Receiving treatment

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy women from 8th week of pregnancy

You may not qualify if:

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

Sponsors & Collaborators

• Mirela Zec: lead

MeSH Terms

Conditions

Anemia

Interventions

Vitamin B 12

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Damir Roje, Prof.

  Clinical Hospital Center, Split

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: master of laboratory medicine diagnostics

Model Details: randomized clinical trial

Study Record Dates

• First Submitted: April 6, 2018
• First Posted: May 11, 2018
• Study Start: September 15, 2011
• Primary Completion: December 23, 2012
• Study Completion: December 23, 2012
• Last Updated: May 11, 2018

Record last verified: 2018-05