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

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy Anemia; Vitamin C Anemia
• Intervention / Treatment: Drug: Vitamin C 500 MG Oral Tablet

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lalitpan Srimaneesiri, M.D.; Phone Number: 0815645290; Email: beamsish@gmail.com
• Study Contact Backup: Name: Lattaporn Pattanawichan, M.D.; Phone Number: 081-4317833; Email: eicky_lp@hotmail.com

Study Locations

• Thailand
  • Ratchathewi
    • Phaya Thai, Ratchathewi, Thailand, 10400
      • Recruiting
      • Rajavithi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Drug: Vitamin C 500 MG Oral Tablet; compare between Vitamin C with iron supplement and iron supplement alone in prevention of anemia in pregnancy.
No Intervention: Iron supplementation alone; Iron supplement alone Drug: Triferdine Component: Iodine 0.15 mg, Iron 60.81 mg, Folic acid 0.4 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
ratio of vitamin C	To study the ratio of vitamin C and iron supplement in prevention of anemia in pregnancy.	2 months after intervention
side effects after receiving vitamin C	To study the side effects after receiving vitamin C during pregnancy.	2 months after intervention

Collaborators and Investigators

• Sponsor: Rajavithi Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2023
• Primary Completion (Estimated): June 27, 2024
• Study Completion (Estimated): June 27, 2024

Study Registration Dates

• First Submitted: July 27, 2023
• First Submitted That Met QC Criteria: July 27, 2023
• First Posted (Actual): August 3, 2023

Study Record Updates

• Last Update Posted (Actual): August 3, 2023
• Last Update Submitted That Met QC Criteria: July 27, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Vitamin C, Pregnancy with anemia
• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia
• Other Study ID Numbers: 118/2566

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No