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

• ClinicalTrials.gov Identifier: NCT05975125
• Recruitment Status: Recruiting
• First Posted: August 3, 2023
• Last Update Posted: August 3, 2023
• Sponsor: Rajavithi Hospital
• Information provided by (Responsible Party): Rajavithi Hospital

Tracking Information

• First Submitted Date: July 27, 2023
• First Posted Date: August 3, 2023
• Last Update Posted Date: August 3, 2023
• Actual Study Start Date: June 28, 2023
• Estimated Primary Completion Date: June 27, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 27, 2023)

To compare hemoglobin and hematocrit levels [ Time Frame: 2 months after intervention ]

To compare hemoglobin and hematocrit levels between groups receiving vitamin C with iron and the group receiving only iron supplement

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: July 27, 2023)

• maternal and fetal pregnancy outcomes [ Time Frame: after intervention until delivery ]
  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.
• ratio of vitamin C [ Time Frame: 2 months after intervention ]
  To study the ratio of vitamin C and iron supplement in prevention of anemia in pregnancy.
• side effects after receiving vitamin C [ Time Frame: 2 months after intervention ]
  To study the side effects after receiving vitamin C during pregnancy.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention

Condition

• Vitamin C 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.

Study Arms

• 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)

  Intervention: Drug: Vitamin C 500 MG Oral Tablet
• No Intervention: Iron supplementation alone
  Iron supplement alone Drug: Triferdine Component: Iodine 0.15 mg, Iron 60.81 mg, Folic acid 0.4 mg

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: July 27, 2023): 100
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 27, 2024
• Estimated Primary Completion Date: June 27, 2024 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Pregnant woman

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Lalitpan Srimaneesiri, M.D.; 0815645290; beamsish@gmail.com

Contact: Lattaporn Pattanawichan, M.D.; 081-4317833; eicky_lp@hotmail.com

• Listed Location Countries: Thailand

Administrative Information

• NCT Number: NCT05975125
• Other Study ID Numbers: 118/2566
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• 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

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Rajavithi Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Rajavithi Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Rajavithi Hospital
• Verification Date: June 2023