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

NCT05975125 | Completed DMC

• 1 other identifier: 118/2566
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin C Anemia; Pregnancy Anemia

Keywords

Vitamin C, Pregnancy with anemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• maternal and fetal pregnancy outcomes

  after intervention until delivery

• ratio of vitamin C

  2 months after intervention

• side effects after receiving vitamin C

  2 months after intervention

Study Arms (2)

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)

Drug: Vitamin C 500 MG Oral Tablet

Iron supplementation alone

NO INTERVENTION

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

Interventions

Vitamin C 500 MG Oral Tablet DRUG

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

Iron supplement with Vitamin C

Eligibility Criteria

• Gender Eligibility Details: Pregnant woman
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 18.
• \. 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Department of Medical Services Ministry of Public Health of Thailand: lead

Study Sites (1)

Rajavithi

Phaya Thai, ratchathewi, 10400, Thailand

Location

MeSH Terms

Interventions

Ascorbic Acid; Tablets

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2023
• First Posted: August 3, 2023
• Study Start: June 28, 2023
• Primary Completion: June 27, 2024
• Study Completion: June 27, 2024
• Last Updated: November 14, 2024

Record last verified: 2023-06

Locations

TH (1)