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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02221752
Enrollment
2367
Registered
2014-08-20
Start date
2009-06-30
Completion date
2011-12-31
Last updated
2014-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron Deficiency, Iron Deficiency Anemia

Keywords

iron deficiency, iron deficiency anemia, infant, pregnancy

Brief 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. 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.

Interventions

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.

DIETARY_SUPPLEMENTFolic acid

Mothers randomized to receive 2 capsules per day: one with placebo and one with 0.40 mg folic acid from enrollment to delivery.

Sponsors

Vifor Pharma
CollaboratorINDUSTRY
Zhao gengli
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Maternal iron status at follow-up prenatal visit26-30 weeks

Secondary

MeasureTime frame
Cord-blood iron statusdelivery
Infant gestational agedelivery
Infant birth weightdelivery

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026