Vitamin B12 Supplementation in Addition to Folic Acid and Iron Improves Hematological and Biochemical Markers in Pregnancy: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 主要终点
- Change of Red blood cells (RBC) count in first and second trimester
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •healthy women from 8th week of pregnancy
排除标准
- •existence of hypertension
- •existence of diabetes
- •existence of genetic abnormalities
- •previous miscarriage
研究组 & 干预措施
Control group
Standard prenatal care (custom folic acid therapy and iron supplements)
Receiving treatment
Adding vitamin B12 at a dose of 5 μg / 100 days, custom folic acid therapy and iron supplements
干预措施: vitamin b12 (Dietary Supplement)
结局指标
主要结局
Change of Red blood cells (RBC) count in first and second trimester
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy
unsaturated iron binding capacity in SI units (µmol/L)
次要结局
- 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)
- Change of Monocytes in first and second trimester(at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy)
- Change of Eosinophils in first and second trimester(at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy)
- Change of Basophils in first and second trimester(at two time points: on the 8th-10th and 22nd-24th weeks of pregnancy)
研究者
Mirela Zec
master of laboratory medicine diagnostics
University of Split, School of Medicine