Impact of Iron/Folic Acid vs Folic Acid Supplements During Pregnancy on Maternal and Child Health

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.

Conditions

• Iron Deficiency
• Iron Deficiency Anemia

Interventions

DIETARY_SUPPLEMENT

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.

DIETARY_SUPPLEMENT

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.

Sponsors & Collaborators

• Zhao gengli

  lead OTHER

• Vifor Pharma

  collaborator INDUSTRY

Principal Investigators

• Zhao Gengli, MD · Peking University First Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-06-30

Primary Completion

2011-12-31

Completion

2011-12-31

Countries

• China

Study Locations