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

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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Vitamin C Anemia Pregnancy Anemia Drug: Vitamin C 500 MG Oral Tablet Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Effect of Vitamin C for Iron Supplementation During Pregnancy With Risk of Anemia
Actual Study Start Date : June 28, 2023
Estimated Primary Completion Date : June 27, 2024
Estimated Study Completion Date : June 27, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. side effects after receiving vitamin C [ Time Frame: 2 months after intervention ]
    To study the side effects after receiving vitamin C during pregnancy.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant woman
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05975125


Contacts
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Contact: Lalitpan Srimaneesiri, M.D. 0815645290 beamsish@gmail.com
Contact: Lattaporn Pattanawichan, M.D. 081-4317833 eicky_lp@hotmail.com

Locations
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Thailand
Rajavithi Recruiting
Phaya Thai, Ratchathewi, Thailand, 10400
Sponsors and Collaborators
Rajavithi Hospital
More Information
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Responsible Party: Rajavithi Hospital
ClinicalTrials.gov Identifier: NCT05975125    
Other Study ID Numbers: 118/2566
First Posted: August 3, 2023    Key Record Dates
Last Update Posted: August 3, 2023
Last Verified: June 2023

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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
Keywords provided by Rajavithi Hospital:
Vitamin C, Pregnancy with anemia
Additional relevant MeSH terms:
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Anemia
Hematologic Diseases