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Trial of Pre-Pregnancy Supplements (TOPPS)

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ClinicalTrials.gov Identifier: NCT01183572
Recruitment Status : Completed
First Posted : August 17, 2010
Last Update Posted : September 11, 2012
Sponsor:
Collaborator:
Ifakara Health Institute
Information provided by (Responsible Party):
Wafaie Fawzi, Harvard School of Public Health

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.

Condition or disease Intervention/treatment
Anemia Dietary Supplement: Multivitamins, Folic Acid, and Iron Dietary Supplement: Folic Acid and Iron Dietary Supplement: Folic Acid

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 802 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Trial of Pre-Pregnancy Supplements
Study Start Date : August 2010
Primary Completion Date : January 2012
Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Folic Acid and Iron
0.4mg of folic acid and 30 mg elemental iron taken daily for 6 months
Dietary Supplement: Folic Acid and Iron
Daily oral dose of 30 mg elemental iron, 0.4 mg folic acid
Placebo Comparator: Folic Acid
0.4mg of folic acid taken daily for 6 months
Dietary Supplement: Folic Acid
Daily oral dose of 0.4 mg folic acid
Active Comparator: 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.
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



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   15 Years to 29 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01183572


Locations
Tanzania
Ifakara Health Institute
Rufiji, Tanzania
Sponsors and Collaborators
Harvard School of Public Health
Ifakara Health Institute
Investigators
Principal Investigator: Wafaie W Fawzi, MD, DrPH Harvard School of Public Health
Principal Investigator: Honorati M Masanja, PhD Ifakara Health Institute

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Wafaie Fawzi, Chair, Department of Global Health and Population, Harvard School of Public Health
ClinicalTrials.gov Identifier: NCT01183572     History of Changes
Other Study ID Numbers: 0055/07
First Posted: August 17, 2010    Key Record Dates
Last Update Posted: September 11, 2012
Last Verified: September 2012

Keywords provided by Wafaie Fawzi, Harvard School of Public Health:
multivitamins
folate
iron
periconception

Additional relevant MeSH terms:
Iron
Folic Acid
Vitamin B Complex
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hematinics
Vitamins