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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02221752
Recruitment Status : Completed
First Posted : August 20, 2014
Last Update Posted : August 20, 2014
Sponsor:
Collaborator:
Vifor Inc.
Information provided by (Responsible Party):
Zhao gengli, Peking University First Hospital

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.


Condition or disease Intervention/treatment Phase
Iron Deficiency Iron Deficiency Anemia Dietary Supplement: Ferrous Sulfate + folic acid Dietary Supplement: Folic acid Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2367 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Study Start Date : June 2009
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011


Arm Intervention/treatment
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.
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.

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.
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.




Primary Outcome Measures :
  1. Maternal iron status at follow-up prenatal visit [ Time Frame: 26-30 weeks ]
  2. Maternal iron status at follow-up prenatal visit [ Time Frame: 36-40 weeks ]

Secondary Outcome Measures :
  1. Cord-blood iron status [ Time Frame: delivery ]
  2. Infant gestational age [ Time Frame: delivery ]
  3. Infant birth weight [ Time Frame: delivery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02221752


Locations
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China
Peking University First Hospital
Beijing, China, 100034
Sponsors and Collaborators
Zhao gengli
Vifor Inc.
Investigators
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Principal Investigator: Zhao Gengli, MD Peking University First Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Zhao gengli, Associate Professor, Peking University First Hospital
ClinicalTrials.gov Identifier: NCT02221752    
Other Study ID Numbers: Vifor/PFH supplement trial
First Posted: August 20, 2014    Key Record Dates
Last Update Posted: August 20, 2014
Last Verified: August 2014
Keywords provided by Zhao gengli, Peking University First Hospital:
iron deficiency
iron deficiency anemia
infant
pregnancy
Additional relevant MeSH terms:
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Anemia, Iron-Deficiency
Anemia
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Iron
Folic Acid
Vitamin B Complex
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Hematinics
Vitamins