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Sponsored by: |
Centers for Disease Control and Prevention |
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Information provided by: | Centers for Disease Control and Prevention |
ClinicalTrials.gov Identifier: | NCT00133744 |
The purpose of this study is to determine whether a daily prenatal supplement of iron plus folic acid or a daily prenatal supplement with multiple vitamins and minerals given to women from their first prenatal visit through delivery reduces perinatal mortality compared with a daily prenatal supplement of folic acid alone.
Condition | Intervention | Phase |
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Perinatal Mortality Stillbirth Neonatal Mortality |
Dietary Supplement: folic acid Dietary Supplement: folic acid plus iron Dietary Supplement: supplements with multiple vitamins and minerals |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Impact of Iron/Folic Acid Versus Multimicronutrient Versus Folic Acid Supplements During Pregnancy on Mortality, Morbidity, and Complications During Pregnancy, Labor, and Delivery: A Randomized Controlled Trial in China |
Estimated Enrollment: | 23082 |
Study Start Date: | May 2006 |
Estimated Study Completion Date: | March 2010 |
Arms | Assigned Interventions |
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A, 1: Active Comparator |
Dietary Supplement: folic acid
pills by mouth, one per day, from the first prenatal visit until delivery, 400 micrograms (mcg) folic acid
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A, 2: Experimental |
Dietary Supplement: folic acid plus iron
pills by mouth, one per day, from the first prenatal visit until delivery, 400 mcg folic acid, 30 mg Fe
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A, 3: Experimental
Multiple micronutrient supplement
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Dietary Supplement: supplements with multiple vitamins and minerals
pills, one per day, from the first prenatal visit until delivery; folic acid 400 mcg, Fe 30 mg, vitamin(vit) A 800 mcg, vit E 10 mg, vit D 5 mcg, vit C 70 mg, vit B1 1.4 mg, vit B2 1.4 mg, vit B6 1.9 mg, vit B12 2.6 mcg, Niacin 18 mg, Zn 15 mg, Cu 2mg, Iodine 150 mcg, Selenium 65 mcg
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In the project area in China, the rate of perinatal mortality (stillbirths and infant deaths within 6 days of birth) is two times that of the United States. Causes of perinatal mortality include, but are not limited to, low birth weight and preterm delivery. Anemia (low hemoglobin) among pregnant women is associated with low birth weight and preterm delivery and also is elevated in the project area. Supplements of iron, folic acid, and other vitamins and minerals can prevent anemia among pregnant women, but the effects of these supplements on other maternal and infant health outcomes are unclear.
Since 1993, the People's Republic of China has recommended that newly married women, and those who plan pregnancy, take 400μg of folic acid daily through the first trimester of pregnancy. Although WHO recommends that pregnant women take iron and folic acid supplements, there is currently no national recommendation that pregnant women in China take iron or other vitamin or mineral supplements (other than folic acid). UNICEF is now testing a prenatal vitamin and mineral supplement in programs to prevent low birth weight. Our study will provide additional information about the health impact of the UNICEF prenatal supplement versus an iron and folic acid supplement versus folic acid alone.
Comparisons:
Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Mary E Cogswell, DrPH, RN | 770-488-6053 | MCogswell@cdc.gov |
Contact: Mei Zuguo, MD, MPH | 770-488-5864 | ZMei@cdc.gov |
China, Hebei | |
Laoting Maternal and Child Health Institute | Recruiting |
Laoting, Hebei, China, 063600 | |
Contact: Lan Liu, MD, MPH 86-10-8280-1759 Liulan@ncmih.bjmu.edu.cn | |
Fengrun Maternal and Child Health Institute | Recruiting |
Fengrun, Hebei, China, 064000 | |
Contact: Wei Chang, MD 86-10-8280-1760 ext 108 Changwei@ncmih.bjmu.edu.cn | |
Xianghe Maternal and Child Health Institute | Recruiting |
Xianghe, Hebei, China, 065400 | |
Contact: Hui Zhang, MD 86-10-8280-1760 ext 115 Zhanghui@ncmih.bjmu.edu.cn | |
Mancheng Maternal and Child Health Institute | Recruiting |
Mancheng, Hebei, China, 072150 | |
Contact: Yinghui Liu, MD, PhD 86-10-8280-1760 ext 126 Liuyh@ncmih.bjmu.edu.cn | |
Yuanshi Maternal and Child Health Institute | Recruiting |
Yuanshi, Hebei, China, 051130 | |
Contact: Weihong Liu, MD, MPH 86-10-8280-1759 Liuwh@ncmih.bjmu.edu.cn |
Principal Investigator: | Zhu Li, MD, MPH | National Center for Maternal and Infant Health, Peking University Health Science Center, Beijing China |
Study Director: | Jianmeng Liu, MD, PhD | National Center for Maternal and Infant Health, Peking University Health Science Center, Beijing China |
Study ID Numbers: | CDC-NCCDPHP-4084 |
Study First Received: | August 22, 2005 |
Last Updated: | September 20, 2007 |
ClinicalTrials.gov Identifier: | NCT00133744 |
Health Authority: | United States: Federal Government |
pregnancy vitamins minerals supplements mortality prenatal perinatal |
anemia birthweight preterm iron micronutrients Stillbirths Early neonatal deaths |
Birth Weight Death Hydroxocobalamin Anemia Thiamine Vitamin B 12 Vitamin B 6 |
Folic Acid Selenium Nicotinic Acids Iodine Pyridoxine Iron Niacin |
Vitamin B Complex Hematinics Therapeutic Uses Growth Substances Vitamins |
Hematologic Agents Physiological Effects of Drugs Micronutrients Pharmacologic Actions |