Trial of Pre-Pregnancy Supplements

Not Applicable

Completed

• Conditions: Anemia
• Interventions: Dietary Supplement: Folic Acid; Dietary Supplement: Folic Acid and Iron; Dietary Supplement: Multivitamins, Folic Acid, and Iron

• Registration Number: NCT01183572
• Lead Sponsor: Harvard School of Public Health (HSPH)

Brief Summary

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

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 Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-08-13
• Study First Submitted QC: 2010-08-13
• Study First Posted: 2010-08-17
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-08
• Last Update Posted: 2012-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 802

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Folic Acid	Folic Acid	0.4mg of folic acid taken daily for 6 months
Folic Acid and Iron	Folic Acid and Iron	0.4mg of folic acid and 30 mg elemental iron taken daily for 6 months
Multivitamins, Folic Acid, and Iron	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Weight Gain during intervention	6 months following the start of the intervention	Weight gain during intervention will be defined as the difference in weight between weight at randomization and weight at 6 months of intervention.
Mid Upper Arm Circumference	6 months following the start of the intervention
Peripheral malaria parasitemia	6 months following the start of the intervention	Peripheral malaria parasitemia will be defined as fever in the past 72 hours with any malaria parasitemia in peripheral blood.

Trial Locations

Locations (1)

Ifakara Health Institute; 🇹🇿 Rufiji, Tanzania