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Trial of Pre-Pregnancy Supplements

NCT ID: NCT01183572

Last Updated: 2012-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

802 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2012-01-31

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.

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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.

Conditions

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Anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Folic Acid and Iron

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

Group Type ACTIVE_COMPARATOR

Folic Acid and Iron

Intervention Type DIETARY_SUPPLEMENT

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

Folic Acid

0.4mg of folic acid taken daily for 6 months

Group Type PLACEBO_COMPARATOR

Folic Acid

Intervention Type DIETARY_SUPPLEMENT

Daily oral dose of 0.4 mg folic acid

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.

Group Type ACTIVE_COMPARATOR

Multivitamins, Folic Acid, and Iron

Intervention Type DIETARY_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

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

Folic Acid and Iron

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

Intervention Type DIETARY_SUPPLEMENT

Folic Acid

Daily oral dose of 0.4 mg folic acid

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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).
Minimum Eligible Age

15 Years

Maximum Eligible Age

29 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ifakara Health Institute

OTHER

Sponsor Role collaborator

Harvard School of Public Health (HSPH)

OTHER

Sponsor Role lead

Responsible Party

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Wafaie Fawzi

Chair, Department of Global Health and Population

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wafaie W Fawzi, MD, DrPH

Role: PRINCIPAL_INVESTIGATOR

Harvard School of Public Health (HSPH)

Honorati M Masanja, PhD

Role: PRINCIPAL_INVESTIGATOR

Ifakara Health Institute

Locations

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Ifakara Health Institute

Rufiji, , Tanzania

Site Status

Countries

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Tanzania

References

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Gunaratna NS, Masanja H, Mrema S, Levira F, Spiegelman D, Hertzmark E, Saronga N, Irema K, Shuma M, Elisaria E, Fawzi W. Multivitamin and iron supplementation to prevent periconceptional anemia in rural tanzanian women: a randomized, controlled trial. PLoS One. 2015 Apr 23;10(4):e0121552. doi: 10.1371/journal.pone.0121552. eCollection 2015.

Reference Type DERIVED
PMID: 25905863 (View on PubMed)

Other Identifiers

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0055/07

Identifier Type: -

Identifier Source: org_study_id

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