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

Sponsor
Rajavithi Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05975125
Collaborator
(none)
100
1
2
12
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Study Details

Study Description

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
  • Drug: Vitamin C 500 MG Oral Tablet
N/A

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

Study Type:
Interventional
Anticipated 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 :
Jun 28, 2023
Anticipated Primary Completion Date :
Jun 27, 2024
Anticipated Study Completion Date :
Jun 27, 2024

Arms and Interventions

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

Primary Outcome Measures

  1. To compare hemoglobin and hematocrit levels [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 [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 [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 [2 months after intervention]

    To study the side effects after receiving vitamin C during pregnancy.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

  6. 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

Locations

Site City State Country Postal Code
1 Rajavithi Phaya Thai Ratchathewi Thailand 10400

Sponsors and Collaborators

  • Rajavithi Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rajavithi Hospital
ClinicalTrials.gov Identifier:
NCT05975125
Other Study ID Numbers:
  • 118/2566
First Posted:
Aug 3, 2023
Last Update Posted:
Aug 3, 2023
Last Verified:
Jun 1, 2023
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 3, 2023