Trial of Pre-Pregnancy Supplements

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Trial of Pre-Pregnancy Supplements

Conditions
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Anemia

Intervention / Treatment
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* Dietary Supplement: Multivitamins, Folic Acid, and Iron
* Dietary Supplement: Folic Acid and Iron
* Dietary Supplement: Folic Acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Girls aged > =15 years and <= 29 years Have not missed a menstrual period during recruitment (no amenorrhea) Has not been pregnant or given birth within the last 6 months Intend to stay in the study area for at least 6 months after enrollment Have provided written informed consent Exclusion Criteria: Amenorrhea or confirmed pregnancy at screening or enrollment. Has given birth within 6 months Already taking long-term vitamin supplementation. Any severe illness requiring hospitalization at screening or enrollment (women who have been deemed to have recovered will be eligible once they return home).

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 29 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Folic Acid and Iron<br>0.4mg of folic acid and 30 mg elemental iron taken daily for 6 months | Dietary Supplement: Folic Acid and Iron<br>* Daily oral dose of 30 mg elemental iron, 0.4 mg folic acid<br>|
| Placebo Comparator: Folic Acid<br>0.4mg of folic acid taken daily for 6 months | Dietary Supplement: Folic Acid<br>* Daily oral dose of 0.4 mg folic acid<br>|
| Active Comparator: Multivitamins, Folic Acid, and Iron<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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multivitamins, folate, iron, periconception