- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02221752
Impact of Iron/Folic Acid vs Folic Acid Supplements During Pregnancy on Maternal and Child Health
Impact of Iron/Folic Acid Versus Folic Acid Supplements During Pregnancy on Maternal and Children's Health: A Randomized Controlled Trial in China
According to a national study in 2002, the prevalence of ID, IDA, and ID+IDA among pregnant women in China was 42.6%, 9.1%, and 61.7% respectively. A similar study in Hebei province at the same time showed that the prevalence of IDA among pregnant and lactating mothers was 46.39% and 47.21% respectively. There was a significant difference between urban and rural areas. Women living in rural areas had higher chances of having IDA (p<0.01). WHO and UNICEF recommend taking iron, folic acid and multiple micronutrients during pregnancy. However, we don't know much about their influence on maternal and infant health and their clinical effectiveness. Health Department of China recommends taking 400ug folic acid before pregnancy and during early pregnancy. But for various reasons, not all expecting mothers take this advice. Besides, we don't have a national level technical standard of how to take nutrition supplements during pregnancy. Therefore, it's crucial for us to study if iron/folic acid or folic acid only can prevent perinatal complications, as well as their influences on infant and toddler health.
The purpose of this study is to test whether taking iron/folic acid and folic acid only from early pregnancy until delivery will lower the chances of pregnancy complications, and to see how supplements affect gestation results. As well, it will evaluate a) whether taking iron supplement during pregnancy can prevent IDA during pregnancy; b) whether taking iron supplement can increase mother and fetus iron storage; and c) how mother's iron level affects newborn's iron level. We hope to understand nutrition conditions during pregnancy and investigate the relations between pregnancy diet and complications during pregnancy, weight gain during pregnancy, and newborn birth weight. We will evaluate the influence of taking iron and folic acid during pregnancy on the health of infants and toddlers.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Beijing, China, 100034
- Peking University first hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- uncomplicated singleton pregnancy, first enrollment visit ≤ 20 weeks gestation -
Exclusion Criteria:
- < 18 years of age
- did not live in the county
- did not anticipate delivery at participating hospital
- were not mentally competent
- had a chronic health problem or hemoglobin < 100 g/L at the initial visit
- were taking iron at the time.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Folic acid
Mothers randomized to receive 2 capsules per day: one with placebo and one with 0.40 mg folic acid from enrollment to delivery.
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Mothers randomized to receive 2 capsules per day: one with placebo and one with 0.40 mg folic acid from enrollment to delivery.
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Experimental: Ferrous Sulfate + folic acid
Mothers randomized to receive 2 capsules per day: one with iron (300 mg ferrous sulfate [60 mg elemental iron]) and the other with 0.40 mg folic acid from enrollment to delivery.
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Mothers randomized to receive 2 capsules per day: one with iron (300 mg ferrous sulfate [60 mg elemental iron]) and the other with 0.40 mg folic acid from enrollment to delivery.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maternal iron status at follow-up prenatal visit
Time Frame: 26-30 weeks
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26-30 weeks
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Maternal iron status at follow-up prenatal visit
Time Frame: 36-40 weeks
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36-40 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cord-blood iron status
Time Frame: delivery
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delivery
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Infant gestational age
Time Frame: delivery
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delivery
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Infant birth weight
Time Frame: delivery
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delivery
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Zhao Gengli, MD, Peking University first hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Vifor/PFH supplement trial
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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