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

NCT ID: NCT05975125

Last Updated: 2024-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-28
• Study Completion Date: 2024-06-27

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.

Conditions

Vitamin C Anemia; Pregnancy Anemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Iron supplement with Vitamin C

Vitamin C with Iron supplement

Drug:

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

Group Type: EXPERIMENTAL

Vitamin C 500 MG Oral Tablet

Intervention Type: DRUG

compare between Vitamin C with iron supplement and iron supplement alone in prevention of anemia in pregnancy.

Iron supplementation alone

Iron supplement alone Drug: Triferdine Component: Iodine 0.15 mg, Iron 60.81 mg, Folic acid 0.4 mg

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Vitamin C 500 MG Oral Tablet

compare between Vitamin C with iron supplement and iron supplement alone in prevention of anemia in pregnancy.

Intervention Type: DRUG

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Department of Medical Services Ministry of Public Health of Thailand

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Rajavithi

Phaya Thai, ratchathewi, Thailand

Countries

Thailand

Other Identifiers

118/2566

Identifier Type: -

Identifier Source: org_study_id