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| Name | Class |
|---|---|
| Ifakara Health Institute | OTHER |
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The purpose of this study is to determine whether daily oral supplements of multivitamins (including vitamins B-complex, C and E) along with Iron and folic acid given to non-pregnant women results in lower prevalence of anemia in preparation for pregnancy when compared to daily iron and folic acid supplements or folic acid alone.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Folic Acid and Iron | Active Comparator | 0.4mg of folic acid and 30 mg elemental iron taken daily for 6 months |
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| Folic Acid | Placebo Comparator | 0.4mg of folic acid taken daily for 6 months |
|
| Multivitamins, Folic Acid, and Iron | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multivitamins, Folic Acid, and Iron | Dietary Supplement | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Anemia | Anemia will be defined as hemoglobin < 12gm/dL at 6 months of intervention. Hemoglobin concentration will also be analyzed as a continuous outcome. | 6 months following the start of the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Weight Gain during intervention | Weight gain during intervention will be defined as the difference in weight between weight at randomization and weight at 6 months of intervention. | 6 months following the start of the intervention |
| Mid Upper Arm Circumference |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wafaie W Fawzi, MD, DrPH | Harvard School of Public Health (HSPH) | Principal Investigator |
| Honorati M Masanja, PhD | Ifakara Health Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ifakara Health Institute | Rufiji | Tanzania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25905863 | Derived | Gunaratna NS, Masanja H, Mrema S, Levira F, Spiegelman D, Hertzmark E, Saronga N, Irema K, Shuma M, Elisaria E, Fawzi W. Multivitamin and iron supplementation to prevent periconceptional anemia in rural tanzanian women: a randomized, controlled trial. PLoS One. 2015 Apr 23;10(4):e0121552. doi: 10.1371/journal.pone.0121552. eCollection 2015. |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C067316 | Geritol |
| D005492 | Folic Acid |
| D007501 | Iron |
| ID | Term |
|---|---|
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Folic Acid and Iron | Dietary Supplement | Daily oral dose of 30 mg elemental iron, 0.4 mg folic acid |
|
| Folic Acid | Dietary Supplement | Daily oral dose of 0.4 mg folic acid |
|
| 6 months following the start of the intervention |
| Peripheral malaria parasitemia | Peripheral malaria parasitemia will be defined as fever in the past 72 hours with any malaria parasitemia in peripheral blood. | 6 months following the start of the intervention |
| D006571 | Heterocyclic Compounds |
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
| D008670 | Metals |