Impact of Prenatal Vitamin/Mineral Supplements on Perinatal Mortality

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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: Infants of women who receive daily prenatal supplements that contain 400μg folic acid alone, will be compared with infants of women who receive daily supplements that contain 30 mg iron and 400 μg folic acid. Infants of women who receive daily supplements that contain 30 mg iron and 400 μg folic acid will be compared with infants of women who receive a daily supplement containing 30 mg iron, 400μg folic acid and other vitamins and minerals (UNICEF formulation).

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

Conditions
-----------------
Perinatal Mortality, Stillbirth, Neonatal Mortality

Intervention / Treatment
-----------------
* Dietary Supplement: folic acid
* Dietary Supplement: folic acid plus iron
* Dietary Supplement: supplements with multiple vitamins and minerals


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Live in one of the study counties (Laoting, Mancheng, Fengrun, Xianghe, Yuanshi) Can follow instructions Can swallow pills Exclusion Criteria: >= 20 weeks gestation at enrollment Previous live birth Anemic (hemoglobin [Hb] <10 g/dl in 1st trimester and < 9.5 g/dl in 2nd trimester) at enrollment Current use of iron or other vitamin or mineral supplements (except folic acid) Age < 20 years at enrollment Under treatment for anemia at enrollment Refuse to participate

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A, 1<br> | Dietary Supplement: folic acid<br>* pills by mouth, one per day, from the first prenatal visit until delivery, 400 micrograms (mcg) folic acid<br>|
| Experimental: A, 2<br> | Dietary Supplement: folic acid plus iron<br>* pills by mouth, one per day, from the first prenatal visit until delivery, 400 mcg folic acid, 30 mg Fe<br>|
| Experimental: A, 3<br>Multiple micronutrient supplement | Dietary Supplement: supplements with multiple vitamins and minerals<br>* 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<br>* Other names: UNIMMAP;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perinatal mortality, i.e., the number of stillbirths (fetal deaths of 28 weeks or more of gestation) and the number of deaths within the first 0-6 days of life per 1000 births (live births and stillbirths) |  | 20 weeks gestation to 6 days postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal anemia |  | 24-28 weeks gestation | 
| Maternal anemia |  | 4-8 weeks postpartum | 
| Infant gestational age at birth, preterm delivery |  | delivery | 
| Infant birth weight, low birth weight |  | at birth | 
| Infant low weight-for-height |  | infant age 6 months and 12 months | 
| Infant anemia |  | 6 months and 12 months of age | 
| maternal gastrointestinal side effects |  | monthly from a month after enrollment until delivery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pregnancy, vitamins, minerals, supplements, mortality, prenatal, perinatal, anemia, birthweight, preterm, iron, micronutrients, Stillbirths, Early neonatal deaths