Trial of Pre-Pregnancy Supplements (TOPPS)

President and Fellows of Harvard College

Status: Completed

Conditions: Anemia

Treatments: Dietary Supplement: Folic Acid; Dietary Supplement: Multivitamins, Folic Acid, and Iron; Dietary Supplement: Folic Acid and Iron

Study type: Interventional

Funder types: Other

Identifiers

NCT01183572

0055/07

Details and patient eligibility

About

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.

Full 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.

Enrollment: 802 patients

Sex: Female

Ages: 15 to 29 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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802 participants in 3 patient groups, including a placebo group

Folic Acid and Iron

Active Comparator group

Description:

0.4mg of folic acid and 30 mg elemental iron taken daily for 6 months

Treatment:

Dietary Supplement: Folic Acid and Iron

Folic Acid

Placebo Comparator group

Description:

0.4mg of folic acid taken daily for 6 months

Treatment:

Dietary Supplement: Folic Acid

Multivitamins, Folic Acid, and Iron

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Multivitamins, Folic Acid, and Iron