Trial of Pre-Pregnancy Supplements
Từ khóa
trừu tượng
Sự miêu tả
Globally, more than half a million women die from pregnancy or childbirth-related complications, most of them in developing countries. The global community committed to reducing the maternal mortality ratio by three quarters between 1990 and 2015 (MDG5). Women die from a range of complications in pregnancy, childbirth or the postpartum period. 80% of maternal deaths are due to severe bleeding (mostly bleeding postpartum), infections, hypertensive disorders in pregnancy and obstructed labor. Additionally, low birth weight and neonatal mortality are common problems in developing countries. The benefit of periconceptual folate on preventing congenital anomalies has been established in randomized trials; however, the role of other nutrients needs to be examined further. Anemia is strongly associated with adverse perinatal outcomes including maternal mortality and low birthweight.
ngày
| Xác minh lần cuối: | 08/31/2012 |
| Đệ trình đầu tiên: | 08/12/2010 |
| Đăng ký ước tính đã được gửi: | 08/12/2010 |
| Đăng lần đầu: | 08/16/2010 |
| Cập nhật lần cuối được gửi: | 09/07/2012 |
| Cập nhật lần cuối đã đăng: | 09/10/2012 |
| Ngày bắt đầu nghiên cứu thực tế: | 07/31/2010 |
| Ngày hoàn thành chính ước tính: | 12/31/2011 |
| Ngày hoàn thành nghiên cứu ước tính: | 12/31/2011 |
Tình trạng hoặc bệnh tật
Can thiệp / điều trị
Dietary Supplement: Multivitamins, Folic Acid, and Iron
Dietary Supplement: Folic Acid and Iron
Dietary Supplement: Folic Acid
Giai đoạn
Nhóm cánh tay
| Cánh tay | Can thiệp / điều trị |
|---|---|
| Active Comparator: Folic Acid and Iron 0.4mg of folic acid and 30 mg elemental iron taken daily for 6 months | Dietary Supplement: Folic Acid and Iron Daily oral dose of 30 mg elemental iron, 0.4 mg folic acid |
| Placebo Comparator: Folic Acid 0.4mg of folic acid taken daily for 6 months | Dietary Supplement: Folic Acid Daily oral dose of 0.4 mg folic acid |
| Active Comparator: Multivitamins, Folic Acid, and Iron A multivitamin and micronutrient supplement that constitutes 1 RDA of Vitamins A (2500 IU), B1 (1.4 mg), B2 (1.4 mg), B6 (1.9 mg), B12 (2.6 ug), niacin (18 mg), C (70 mg), E (10 mg), and folic acid (0.4 mg)along with 30 mg of elemental iron taken daily for 6 months. | Dietary Supplement: Multivitamins, Folic Acid, and Iron Daily oral dose containing 2500 IU Vitamin A, 1.4 mg Vitamin B1, 1.4 mg Vitamin B2, 2.6 mg Vitamin B12, 1.9 mg Vitamin B6, 18 mg Niacin, 70 mg Vitamin C, 14.9 IU Vitamin E, 30 mg elemental iron, 0.4 mg folic acid |
Đủ tiêu chuẩn
| Tuổi đủ điều kiện để học | 15 Years Đến 15 Years |
| Giới tính đủ điều kiện để nghiên cứu | Female |
| Chấp nhận tình nguyện viên lành mạnh | Đúng |
| Tiêu chí | Inclusion Criteria: 1. Girls aged > =15 years and <= 29 years 2. Have not missed a menstrual period during recruitment (no amenorrhea) 3. Has not been pregnant or given birth within the last 6 months 4. Intend to stay in the study area for at least 6 months after enrollment 5. Have provided written informed consent Exclusion Criteria: 1. Amenorrhea or confirmed pregnancy at screening or enrollment. 2. Has given birth within 6 months 3. Already taking long-term vitamin supplementation. 4. Any severe illness requiring hospitalization at screening or enrollment (women who have been deemed to have recovered will be eligible once they return home). |
Kết quả
Các biện pháp kết quả chính
1. Anemia [6 months following the start of the intervention]
Các biện pháp kết quả thứ cấp
1. Weight Gain during intervention [6 months following the start of the intervention]
2. Mid Upper Arm Circumference [6 months following the start of the intervention]
3. Peripheral malaria parasitemia [6 months following the start of the intervention]
