Iron DeficiencyNCT02221752
Impact of Iron/Folic Acid vs Folic Acid Supplements During Pregnancy on Maternal and Child Health
A study testing Ferrous Sulfate + folic acid and Folic acid in people with Iron Deficiency and Iron Deficiency Anemia, run by Zhao gengli at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Iron Deficiency, Iron Deficiency Anemia
- What is being tested?
- Ferrous Sulfate + folic acid and Folic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,367 participants
- Where
- 1 siteChina
- Study dates
- Jun 2009to Dec 2011
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- uncomplicated singleton pregnancy, first enrollment visit ≤ 20 weeks gestation -
Who cannot join
- < 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
Iron deficiency (ID) is the world's most common single nutrient disorder, differentially affecting pregnant women and infants everywhere. The study was conducted in China, a rapidly developing country where ID often occurs among pregnant women and infants in the absence of generalized undernutrition. The study was a collaboration between Peking University First Hospital and three local hospitals (Sanhe Maternity and Child Health Care Center [MCHC], Sanhe General County Hospital, and Sanhe Hospital of Traditional Chinese Medicine). Eligible pregnant women were enrolled from June 2009 through December 2011 and randomized in a 1:1 ratio to receive iron and folic acid or folic acid only. The study protocol was approved by the institutional review board of Peking University First Hospital, Beijing, China. Women were recruited (n=2367) at their first prenatal visit at Sanhe MCHC. Those with uncomplicated singleton pregnancies and first prenatal visits ≤ 20 weeks gestation were invited to participate. Women were randomized and received 2 supplements: iron/placebo and folic acid. Project personnel instructed the participants to take two capsules per day (one of each kind of supplement) from enrollment to delivery. Participants received a 3-month supply of each supplement upon enrollment and at the second study visit (26-30 weeks). The number of doses received and consumed or missed was recorded by project personnel. The primary outcomes were maternal iron status at follow-up visits (26-30 weeks and 36-40 weeks), cord-blood iron status, and infant gestational age and birth weight. Data analysis compares pregnancy iron level between two study groups and how it relates to pregnancy outcomes, including pregnancy and delivery complications, preterm rate, perinatal death rate, and birth rate. Data analysis also includes evaluating pregnancy nutrition conditions and analyzing associations with weight changes during pregnancy, and rates of pregnancy diabetes, pregnancy high blood pressure, fetus growth restriction, low birth weight, and fetal macrosomia. Up to 75% of pregnant women worldwide are anemic, with about half due to ID. The public health implications of study findings could be profound.
- Conditions
- Iron Deficiency, Iron Deficiency Anemia
- Being tested
- Ferrous Sulfate + folic acid, Folic acid
- Keywords
- iron deficiency, iron deficiency anemia, infant, pregnancy
- Medical subject headings
- Iron Deficiencies, Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferrous Sulfate + folic acidDietary supplement
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.
Folic acidDietary supplement
Mothers randomized to receive 2 capsules per day: one with placebo and one with 0.40 mg folic acid from enrollment to delivery.
| Study group | Role | What they receive |
|---|---|---|
| Folic acid | Experimental | Mothers randomized to receive 2 capsules per day: one with placebo and one with 0.40 mg folic acid from enrollment to delivery. Receives: Dietary Supplement: Folic acid |
| Ferrous Sulfate + folic acid | Experimental | 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. Receives: Dietary Supplement: Ferrous Sulfate + folic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal iron status at follow-up prenatal visit
Measured: 26-30 weeks
Maternal iron status at follow-up prenatal visit
Measured: 36-40 weeks
Secondary outcomes (3)
Cord-blood iron status
Measured: delivery
Infant gestational age
Measured: delivery
Infant birth weight
Measured: delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2014 (estimated)
- Study startJun 2009
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Iron DeficiencyStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,367 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhao gengli
- Sponsor type
- University, hospital or other
- Collaborators
- Vifor Pharma
- Responsible party
- Sponsor-investigator, Zhao gengli, Peking University First Hospital
- Investigators
- Zhao Gengli, MD, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02221752
- Sponsor's protocol ID
- Vifor/PFH supplement trial
- Status last verified
- Aug 2014
- First submitted
- 18 Aug 2014
- Last updated
- 20 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Finkelstein JL, Cuthbert A, Weeks J, Venkatramanan S, Larvie DY, De-Regil LM, Garcia-Casal MN. Daily oral iron supplementation during pregnancy. Cochrane Database Syst Rev. 2024 Aug 15;8(8):CD004736. doi: 10.1002/14651858.CD004736.pub6.
PubMed 39145520Zhao G, Xu G, Zhou M, Jiang Y, Richards B, Clark KM, Kaciroti N, Georgieff MK, Zhang Z, Tardif T, Li M, Lozoff B. Prenatal Iron Supplementation Reduces Maternal Anemia, Iron Deficiency, and Iron Deficiency Anemia in a Randomized Clinical Trial in Rural China, but Iron Deficiency Remains Widespread in Mothers and Neonates. J Nutr. 2015 Aug;145(8):1916-23. doi: 10.3945/jn.114.208678. Epub 2015 Jun 10.
PubMed 26063068
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Iron/Folic Acid Versus Folic Acid Supplements During Pregnancy on Maternal and Children's Health: A Randomized Controlled Trial in China
- ClinicalTrials.gov ID
- NCT02221752
- Acronym / sponsor ID
- Vifor/PFH supplement trial
- Conditions
- Iron Deficiency, Iron Deficiency Anemia
- Keywords
- iron deficiency, iron deficiency anemia, infant, pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,367 participants (actual)
- Lead sponsor
- Zhao gengliUniversity, hospital or other
- Collaborators
- Vifor Pharma
- Study start
- Jun 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 20 Aug 2014 (estimated)
- 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.
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.
Detailed description
Iron deficiency (ID) is the world's most common single nutrient disorder, differentially affecting pregnant women and infants everywhere. The study was conducted in China, a rapidly developing country where ID often occurs among pregnant women and infants in the absence of generalized undernutrition. The study was a collaboration between Peking University First Hospital and three local hospitals (Sanhe Maternity and Child Health Care Center [MCHC], Sanhe General County Hospital, and Sanhe Hospital of Traditional Chinese Medicine). Eligible pregnant women were enrolled from June 2009 through December 2011 and randomized in a 1:1 ratio to receive iron and folic acid or folic acid only. The study protocol was approved by the institutional review board of Peking University First Hospital, Beijing, China. Women were recruited (n=2367) at their first prenatal visit at Sanhe MCHC. Those with uncomplicated singleton pregnancies and first prenatal visits ≤ 20 weeks gestation were invited to participate. Women were randomized and received 2 supplements: iron/placebo and folic acid. Project personnel instructed the participants to take two capsules per day (one of each kind of supplement) from enrollment to delivery. Participants received a 3-month supply of each supplement upon enrollment and at the second study visit (26-30 weeks). The number of doses received and consumed or missed was recorded by project personnel. The primary outcomes were maternal iron status at follow-up visits (26-30 weeks and 36-40 weeks), cord-blood iron status, and infant gestational age and birth weight. Data analysis compares pregnancy iron level between two study groups and how it relates to pregnancy outcomes, including pregnancy and delivery complications, preterm rate, perinatal death rate, and birth rate. Data analysis also includes evaluating pregnancy nutrition conditions and analyzing associations with weight changes during pregnancy, and rates of pregnancy diabetes, pregnancy high blood pressure, fetus growth restriction, low birth weight, and fetal macrosomia. Up to 75% of pregnant women worldwide are anemic, with about half due to ID. The public health implications of study findings could be profound.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Folic acid | Experimental | Dietary Supplement: Folic acidMothers randomized to receive 2 capsules per day: one with placebo and one with 0.40 mg folic acid from enrollment to delivery. |
| Ferrous Sulfate + folic acid | Experimental | Dietary Supplement: Ferrous Sulfate + folic acidMothers 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- uncomplicated singleton pregnancy, first enrollment visit ≤ 20 weeks gestation -
Key exclusion criteria (6 listed)
- < 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
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 |
|---|---|---|
| Ferrous Sulfate + folic acidMothers 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. | Dietary supplement | Ferrous Sulfate + folic acid |
| Folic acidMothers randomized to receive 2 capsules per day: one with placebo and one with 0.40 mg folic acid from enrollment to delivery. | Dietary supplement | Folic acid |
Primary outcome
Maternal iron status at follow-up prenatal visit
Time frame: 26-30 weeks
Maternal iron status at follow-up prenatal visit
Time frame: 36-40 weeks
3 secondary outcomes
Cord-blood iron status
Time frame: delivery
Infant gestational age
Time frame: delivery
Infant birth weight
Time frame: delivery
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 20 Aug 2014.
- Derived from this study: PubMed 39145520Finkelstein JL, Cuthbert A, Weeks J, Venkatramanan S, Larvie DY, De-Regil LM, Garcia-Casal MN. Daily oral iron supplementation during pregnancy. Cochrane Database Syst Rev. 2024 Aug 15;8(8):CD004736. doi: 10.1002/14651858.CD004736.pub6.
- Derived from this study: PubMed 26063068Zhao G, Xu G, Zhou M, Jiang Y, Richards B, Clark KM, Kaciroti N, Georgieff MK, Zhang Z, Tardif T, Li M, Lozoff B. Prenatal Iron Supplementation Reduces Maternal Anemia, Iron Deficiency, and Iron Deficiency Anemia in a Randomized Clinical Trial in Rural China, but Iron Deficiency Remains Widespread in Mothers and Neonates. J Nutr. 2015 Aug;145(8):1916-23. doi: 10.3945/jn.114.208678. Epub 2015 Jun 10.
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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.
Zhao Gengli, MD principal investigator
Peking University First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ferrous Sulfate + folic acid and Folic acid in people with Iron Deficiency and Iron Deficiency Anemia, run by Zhao gengli at 1 site in China.
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 1 inclusion and 6 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 20 Aug 2014. 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 China. 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?
Maternal iron status at follow-up prenatal visit (time frame: 26-30 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02221752, which also lists 2 linked publications.
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 20 Aug 2014.