Vitamin C AnemiaNCT05975125
The Effect of Vitamin C for Iron Supplementation During Pregnancy with Risk of Anemia
A study testing Vitamin C 500 MG Oral Tablet in people with Vitamin C Anemia and Pregnancy Anemia, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vitamin C Anemia, Pregnancy Anemia
- What is being tested?
- Vitamin C 500 MG Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteThailand
- Study dates
- 28 Jun 2023to 27 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Vitamin C Anemia, Pregnancy Anemia
- Being tested
- Vitamin C 500 MG Oral Tablet
- Keywords
- Vitamin C, Pregnancy with anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin C 500 MG Oral TabletDrug
compare between Vitamin C with iron supplement and iron supplement alone in prevention of anemia in pregnancy.
| Study group | Role | What they receive |
|---|---|---|
| Iron supplement with Vitamin C | Experimental | Vitamin C with Iron supplement
Drug:
Vitamin C 500mg Triferdine(Component: Iodine 0.15 mg, Iron 60.81 mg, Folic acid 0.4 mg) Receives: Drug: Vitamin C 500 MG Oral Tablet |
| Iron supplementation alone | No intervention | Iron supplement alone Drug: Triferdine Component: Iodine 0.15 mg, Iron 60.81 mg, Folic acid 0.4 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 months after intervention
Secondary outcomes (3)
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.
Measured: after intervention until delivery
ratio of vitamin C
To study the ratio of vitamin C and iron supplement in prevention of anemia in pregnancy.
Measured: 2 months after intervention
side effects after receiving vitamin C
To study the side effects after receiving vitamin C during pregnancy.
Measured: 2 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start28 Jun 2023
- Primary completion27 Jun 2024
- Study completion27 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin C AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Department of Medical Services Ministry of Public Health of Thailand
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05975125
- Sponsor's protocol ID
- 118/2566
- Status last verified
- Jun 2023
- First submitted
- 27 Jul 2023
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vitamin C for Iron Supplementation During Pregnancy with Risk of Anemia
- ClinicalTrials.gov ID
- NCT05975125
- Acronym / sponsor ID
- 118/2566
- Conditions
- Vitamin C Anemia, Pregnancy Anemia
- Keywords
- Vitamin C, Pregnancy with anemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Department of Medical Services Ministry of Public Health of ThailandOther government
- Study start
- 28 Jun 2023 (actual)
- Primary completion
- 27 Jun 2024 (actual)
- Study completion
- 27 Jun 2024 (actual)
- First posted
- 3 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iron supplement with Vitamin C | Experimental | Drug: Vitamin C 500 MG Oral TabletVitamin C with Iron supplement Drug: Vitamin C 500mg Triferdine(Component: Iodine 0.15 mg, Iron 60.81 mg, Folic acid 0.4 mg) |
| Iron supplementation alone | No intervention | –Iron supplement alone Drug: Triferdine Component: Iodine 0.15 mg, Iron 60.81 mg, Folic acid 0.4 mg |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- Receive vitamin C supplements during the program
- HIV infection
- Iron deficiency anemia or blood diseases such as thalassemia
- Gastrointestinal bleeding
- Antenatal hemorrhage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin C 500 MG Oral Tabletcompare between Vitamin C with iron supplement and iron supplement alone in prevention of anemia in pregnancy. | Drug | Iron supplement with Vitamin C |
Primary outcome
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
3 secondary outcomes
maternal and fetal pregnancy outcomes
Time frame: after intervention until delivery
ratio of vitamin C
Time frame: 2 months after intervention
side effects after receiving vitamin C
Time frame: 2 months after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin C 500 MG Oral Tablet in people with Vitamin C Anemia and Pregnancy Anemia, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare hemoglobin and hematocrit levels (time frame: 2 months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2024.