Vitamin B12 Pregnancy Supplementation

Pregnancy Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03522428
• Other study ID #: dupin
• Status: Completed
• Phase: Phase 4
• Start date: September 15, 2011
• Est. completion date: December 23, 2012

Study information

• Verified date: May 2018
• Source: University of Split, School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 (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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 23, 2012
• Est. primary completion date: December 23, 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• healthy women from 8th week of pregnancy

Exclusion Criteria:

• existence of hypertension

• existence of diabetes

• existence of genetic abnormalities

• smoking

• previous miscarriage

Related Conditions & MeSH terms

• Pregnancy Anemia

Intervention

Dietary Supplement:
• vitamin b12
Vitamin B12 has been added to the experimental group of pregnant women, at a dose of 5 µg / 100 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mirela Zec

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Change of Hematocrit in first and second trimester	volume percentage (%)	at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Change of White Blood Cells (WBC) in first and second trimester	RBC count measured in SI units (Nx10*9/L)	at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
Secondary	Change of Platelet Count in first and second trimester	RBC count measured in SI units (Nx10*9/L)	at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
Secondary	Change of Transferrin in first and second trimester	transferrin serum concentration in SI units (g/L)	at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
Secondary	Change of Neutrophils in first and second trimester	proportion of neutrophils of all white cells (%)	at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
Secondary	Change of Lymphocytes in first and second trimester	proportion of lymphocytes of all white cells (%)	at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
Secondary	Change of Monocytes in first and second trimester	proportion of monocytes of all white cells (%)	at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
Secondary	Change of Eosinophils in first and second trimester	proportion of eosinophils of all white cells (%)	at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
Secondary	Change of Basophils in first and second trimester	proportion of basophils of all white cells (%)	at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy