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临床试验/NCT05975125
NCT05975125已完成不适用

The Effect of Vitamin C for Iron Supplementation During Pregnancy with Risk of Anemia

Rajavithi Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年6月28日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
To compare hemoglobin and hematocrit levels

研究概览

简要总结

Anemia is a common problem during pregnancy. Most studies have demonstrated that anemia during pregnancy have adverse effects on their pregnancy outcome, which is important and should pay attention to prevent and solve such problems. The most common cause of anemia is iron deficiency. Several studies reveal that Vitamin C promotes iron absorption. In this study we will compare between Vitamin C with iron supplement and iron supplement alone in prevention of anemia in pregnancy.

详细描述

Anemia in pregnancy associated with Diabetes during pregnancy 15.9 % Fetal abnormalities in blood oxygen causing fetal non reassuring 9.4% , Preterm delivery 8.2 %, Amniotic fluid insufficiency 1.95 %, 10.6 % of infants had complications after birth, 9.7 % of infants were hospitalized in intensive care units with birth weight less than 2,500 grams . (Low birth weight) 4.9%, anemia also significantly increased the likelihood of blood transfusion during pregnancy.

There is also a study on the risk of developing anemia such as more than 2 pregnancies, Teenage pregnancy, Advanced maternal age more than 35 years old, Mothers with a body mass index below 18 are at increased risk of developing anemia. The most common cause of anemia during pregnancy is iron deficiency. This may be caused by receiving the element. not enough iron or there is a loss of iron from blood loss which is important and should pay attention to prevent and solve such problems. Which Vitamin C promotes iron absorption. Vitamin C combined with iron has been studied. It clearly increases hemoglobin and hematocrit. And is safe for pregnant women and babies. There is also no evidence that vitamin C is a carcinogen, or a cause of birth defects or toxicity. However, there are no studies related to the combination of vitamin C and iron in pregnant women at risk of anemia. To solve the problem and prevent the consequences of the above mentioned anemia. In this study we will compare between Vitamin C with iron supplement and iron supplement alone in prevention of anemia in pregnancy.

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
None

入排标准

性别
Female
接受健康志愿者

入选标准

  • Pregnant woman Antenatal care at Rajavithi Hospital
  • Singleton pregnancy
  • Provide inform consent with both patient and her husband
  • Gestational age between 14-28 weeks
  • Risk of anemia during pregnancy, including more than 2 pregnancies, teenage pregnancy, advanced maternal age over 35 years old, mothers with body mass index below
  • Pregnant women with hemoglobin greater than 10.5 g/dL, hematocrit greater than 32 % in the first antenatal blood results.
  • Giving birth at Rajavithi Hospital
  • Can communicate and understand Thai language very well

排除标准

  • Receive vitamin C supplements during the program
  • HIV infection
  • Iron deficiency anemia or blood diseases such as thalassemia
  • Gastrointestinal bleeding
  • Antenatal hemorrhage
  • Allergic to vitamin C or iron
  • Congenital diseases including kidney disease, liver disease, joint disease and bleeding disorders.
  • Symptoms that indicate infection, such as fever, sore throat, sputum, diarrhea, loose stools, etc.
  • History of iron intake within the past 3 months
  • Received blood components within the past 3 months or while participating in a research project
  • Giving birth during the drug trial

研究组 & 干预措施

Iron supplement with Vitamin C

Experimental

Vitamin C with Iron supplement

Drug:

Vitamin C 500mg Triferdine(Component: Iodine 0.15 mg, Iron 60.81 mg, Folic acid 0.4 mg)

干预措施: Vitamin C 500 MG Oral Tablet (Drug)

结局指标

主要结局

To compare hemoglobin and hematocrit levels

时间窗: 2 months after intervention

To compare hemoglobin and hematocrit levels between groups receiving vitamin C with iron and the group receiving only iron supplement

次要结局

  • side effects after receiving vitamin C(2 months after intervention)
  • maternal and fetal pregnancy outcomes(after intervention until delivery)
  • ratio of vitamin C(2 months after intervention)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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