Trial of Pre-Pregnancy Supplements

Harvard School of Public Health (HSPH)802 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

802

Conditions

Anemia

Interventions

Multivitamins, Folic Acid, and IronDIETARY_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

Folic Acid and IronDIETARY_SUPPLEMENT

Daily oral dose of 30 mg elemental iron, 0.4 mg folic acid

Folic AcidDIETARY_SUPPLEMENT

Daily oral dose of 0.4 mg folic acid

Eligibility

Sex: FEMALEMin age: 15 YearsMax age: 29 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Locations (1)

Ifakara Health Institute

Rufiji, Tanzania

Outcomes

Primary Outcomes

Anemia

Anemia will be defined as hemoglobin \< 12gm/dL at 6 months of intervention. Hemoglobin concentration will also be analyzed as a continuous outcome.

Time frame: 6 months following the start of the intervention

Secondary Outcomes

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.

Time frame: 6 months following the start of the intervention

Mid Upper Arm Circumference

Time frame: 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.

Time frame: 6 months following the start of the intervention

Data from ClinicalTrials.gov

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