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

Pregnancy Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05975125
• Other study ID #: 118/2566
• Status: Recruiting
• Phase: N/A
• Start date: June 28, 2023
• Est. completion date: June 27, 2024

Study information

• Verified date: June 2023
• Source: Rajavithi Hospital
• Contact: Lalitpan Srimaneesiri, M.D.
• Phone: 0815645290
• Email: beamsish[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 27, 2024
• Est. primary completion date: June 27, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Pregnancy Anemia

Intervention

Drug:
• Vitamin C 500 MG Oral Tablet
compare between Vitamin C with iron supplement and iron supplement alone in prevention of anemia in pregnancy.

Locations

Country	Name	City	State
Thailand	Rajavithi	Phaya Thai	Ratchathewi

Sponsors (1)

Lead Sponsor	Collaborator
Rajavithi Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare hemoglobin and hematocrit levels	To compare hemoglobin and hematocrit levels between groups receiving vitamin C with iron and the group receiving only iron supplement	2 months after intervention
Secondary	maternal and fetal pregnancy outcomes	To compare maternal and fetal pregnancy outcomes such as postpartum haemorrhage, blood transfusion after birth, birth body weight, gestational age at childbirth, the health of the baby after birth, etc., among the groups that received vitamin C and iron intake compare with the group that received only iron supplement alone.	after intervention until delivery
Secondary	ratio of vitamin C	To study the ratio of vitamin C and iron supplement in prevention of anemia in pregnancy.	2 months after intervention
Secondary	side effects after receiving vitamin C	To study the side effects after receiving vitamin C during pregnancy.	2 months after intervention