Clinical trial NCT05975125: The Effect of Vitamin C for Iron Supplementation During Pregnancy with Risk of Anemia
Official title: The Effect of Vitamin C for Iron Supplementation During Pregnancy with Risk of Anemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin C Anemia
Pregnancy Anemia
Keywords: Vitamin C, Pregnancy with anemia
Lead sponsor: Department of Medical Services Ministry of Public Health of Thailand
Sponsor class: OTHER_GOV
First posted: 2023-08-03
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Pregnant woman Antenatal care at Rajavithi Hospital
2. Singleton pregnancy
3. Provide inform consent with both patient and her husband
4. Gestational age between 14-28 weeks
5. 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 18.

5. Pregnant women with hemoglobin greater than 10.5 g/dL, hematocrit greater than 32 % in the first antenatal blood results. 6. Giving birth at Rajavithi Hospital 7. Can communicate and understand Thai language very well

Exclusion Criteria:

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

Primary outcomes:
measure: To compare hemoglobin and hematocrit levels
timeFrame: 2 months after intervention
Secondary outcomes:
measure: maternal and fetal pregnancy outcomes
timeFrame: after intervention until delivery
measure: ratio of vitamin C
timeFrame: 2 months after intervention
measure: side effects after receiving vitamin C
timeFrame: 2 months after intervention
Other outcomes:
Locations:
city: Phaya Thai
country: Thailand
facility: Rajavithi
state: Ratchathewi
Study officials:
References: