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OpenTrials
Completed

NCT Number: NCT01183572

Trial of Pre-Pregnancy Supplements

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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Key information

Age range

15 year–29 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ifakara Health Institute

Rufiji, Tanzania

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Girls aged > =15 years and <= 29 years
  • Have not missed a menstrual period during recruitment (no amenorrhea)
  • Has not been pregnant or given birth within the last 6 months
  • Intend to stay in the study area for at least 6 months after enrollment
  • Have provided written informed consent

Exclusion criteria

  • Amenorrhea or confirmed pregnancy at screening or enrollment.
  • Has given birth within 6 months
  • Already taking long-term vitamin supplementation.
  • Any severe illness requiring hospitalization at screening or enrollment (women who have been deemed to have recovered will be eligible once they return home).

Treatment and study plan

Multivitamins, Folic Acid, and Iron

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

Folic Acid and Iron

Dietary Supplement

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

Folic Acid

Dietary Supplement

Daily oral dose of 0.4 mg folic acid

Primary outcomes

  1. Anemia

    Time frame: 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 outcomes

  1. Weight Gain during intervention

    Time frame: 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.

  2. Mid Upper Arm Circumference

    Time frame: 6 months following the start of the intervention

  3. Peripheral malaria parasitemia

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Harvard School of Public Health (HSPH)

Other

Collaborators

  • Ifakara Health Institute

Registry information

Acronym: TOPPS

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Aug 17, 2010
Registry last updated
Sep 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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