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

Primary Purpose

Vitamin C Anemia, Pregnancy Anemia

Status
Recruiting
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Vitamin C 500 MG Oral Tablet
Sponsored by
Rajavithi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Vitamin C Anemia focused on measuring Vitamin C, Pregnancy with anemia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: 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. 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: 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

Sites / Locations

  • RajavithiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Iron supplement with Vitamin C

Iron supplementation alone

Arm Description

Vitamin C with Iron supplement Drug: Vitamin C 500mg Triferdine(Component: Iodine 0.15 mg, Iron 60.81 mg, Folic acid 0.4 mg)

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
ratio of vitamin C
To study the ratio of vitamin C and iron supplement in prevention of anemia in pregnancy.
side effects after receiving vitamin C
To study the side effects after receiving vitamin C during pregnancy.

Full Information

First Posted
July 27, 2023
Last Updated
July 27, 2023
Sponsor
Rajavithi Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05975125
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 28, 2023 (Actual)
Primary Completion Date
June 27, 2024 (Anticipated)
Study Completion Date
June 27, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rajavithi Hospital

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin C Anemia, Pregnancy Anemia
Keywords
Vitamin C, Pregnancy with anemia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Iron supplement with Vitamin C
Arm Type
Experimental
Arm Description
Vitamin C with Iron supplement Drug: Vitamin C 500mg Triferdine(Component: Iodine 0.15 mg, Iron 60.81 mg, Folic acid 0.4 mg)
Arm Title
Iron supplementation alone
Arm Type
No Intervention
Arm Description
Iron supplement alone Drug: Triferdine Component: Iodine 0.15 mg, Iron 60.81 mg, Folic acid 0.4 mg
Intervention Type
Drug
Intervention Name(s)
Vitamin C 500 MG Oral Tablet
Intervention Description
compare between Vitamin C with iron supplement and iron supplement alone in prevention of anemia in pregnancy.
Primary Outcome Measure Information:
Title
To compare hemoglobin and hematocrit levels
Description
To compare hemoglobin and hematocrit levels between groups receiving vitamin C with iron and the group receiving only iron supplement
Time Frame
2 months after intervention
Secondary Outcome Measure Information:
Title
maternal and fetal pregnancy outcomes
Description
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.
Time Frame
after intervention until delivery
Title
ratio of vitamin C
Description
To study the ratio of vitamin C and iron supplement in prevention of anemia in pregnancy.
Time Frame
2 months after intervention
Title
side effects after receiving vitamin C
Description
To study the side effects after receiving vitamin C during pregnancy.
Time Frame
2 months after intervention

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant woman
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. 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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lalitpan Srimaneesiri, M.D.
Phone
0815645290
Email
beamsish@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lattaporn Pattanawichan, M.D.
Phone
081-4317833
Email
eicky_lp@hotmail.com
Facility Information:
Facility Name
Rajavithi
City
Phaya Thai
State/Province
Ratchathewi
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Recruiting

12. IPD Sharing Statement

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

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