NCT01183572

Trial of Pre-Pregnancy Supplements

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 802 (actual)
• Sponsor: Harvard School of Public Health (HSPH) · Academic / Other
• Sex: Female
• Age: 15 Years – 29 Years
• Healthy volunteers: Accepted

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.

Conditions

• Anemia

Interventions

Type	Name	Description
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
DIETARY_SUPPLEMENT	Folic Acid and Iron	Daily oral dose of 30 mg elemental iron, 0.4 mg folic acid
DIETARY_SUPPLEMENT	Folic Acid	Daily oral dose of 0.4 mg folic acid

Timeline

• Start date: 2010-08-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2010-08-17
• Last updated: 2012-09-11

Locations

1 site across 1 country: Tanzania