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CompletedNCT05975125Updated Nov 14, 2024

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

An interventional study of Vitamin C 500 MG Oral Tablet in Vitamin C Anemia and Pregnancy Anemia, sponsored by Department of Medical Services Ministry of Public Health of Thailand. Completed at 1 site in Thailand. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-14.

Sponsored by Department of Medical Services Ministry of Public Health of Thailand · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Vitamin C Anemia
  • Pregnancy Anemia

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Keywords

  • Vitamin C, Pregnancy with anemia
03

In context

Anemia

1,733 studies on the registry are indexed under Anemia; 246 are open to participants now.

This study's enrollment of 100 is close to the median of 94 across 1,291 interventional studies indexed under Anemia.

Browse Anemia studies →

Lead sponsor

Department of Medical Services Ministry of Public Health of Thailand is the lead sponsor of 36 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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.
  1. 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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (actual)

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)

    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

Interventions

  • DrugVitamin C 500 MG Oral Tablet

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

06

What researchers measure

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

    Time frame: 2 months after intervention

Secondary outcomes

  1. 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.

    Time frame: after intervention until delivery

  2. ratio of vitamin C

    To study the ratio of vitamin C and iron supplement in prevention of anemia in pregnancy.

    Time frame: 2 months after intervention

  3. side effects after receiving vitamin C

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

    Time frame: 2 months after intervention

07

Study locations

1 site
  • Rajavithi
    Phaya Thai, Ratchathewi 10400, Thailand
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 14, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05975125
Lead sponsor
Department of Medical Services Ministry of Public Health of Thailand
Responsible party
Sponsor
First posted
Aug 3, 2023
Start date
Jun 28, 2023
Primary completion
Jun 27, 2024
Completion
Jun 27, 2024
Last update
Nov 14, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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