Trial of Pre-Pregnancy Supplements (TOPPS)
This study has been completed.
Sponsor:
Harvard School of Public Health
Collaborator:
Ifakara Health Institute
Information provided by (Responsible Party):
Wafaie Fawzi, Harvard School of Public Health
ClinicalTrials.gov Identifier:
NCT01183572
First received: August 13, 2010
Last updated: September 8, 2012
Last verified: September 2012
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Purpose
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 | Intervention |
|---|---|
|
Anemia |
Dietary Supplement: Multivitamins, Folic Acid, and Iron Dietary Supplement: Folic Acid and Iron Dietary Supplement: Folic Acid |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Trial of Pre-Pregnancy Supplements |
Resource links provided by NLM:
Further study details as provided by Harvard School of Public Health:
Primary Outcome Measures:
- Anemia [ Time Frame: 6 months following the start of the intervention ] [ Designated as safety issue: No ]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:
- Weight Gain during intervention [ Time Frame: 6 months following the start of the intervention ] [ Designated as safety issue: No ]Weight gain during intervention will be defined as the difference in weight between weight at randomization and weight at 6 months of intervention.
- Mid Upper Arm Circumference [ Time Frame: 6 months following the start of the intervention ] [ Designated as safety issue: No ]
- Peripheral malaria parasitemia [ Time Frame: 6 months following the start of the intervention ] [ Designated as safety issue: No ]Peripheral malaria parasitemia will be defined as fever in the past 72 hours with any malaria parasitemia in peripheral blood.
| Enrollment: | 802 |
| Study Start Date: | August 2010 |
| Study Completion Date: | January 2012 |
| Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 15 Years to 29 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
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).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
More Information
No publications provided
| 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 |
| Study First Received: | August 13, 2010 |
| Last Updated: | September 8, 2012 |
| Health Authority: | United States: Institutional Review Board Tanzania: Food & Drug Administration Tanzania: National Institute for Medical Research |
Keywords provided by Harvard School of Public Health:
|
multivitamins folate iron periconception |
Additional relevant MeSH terms:
|
Anemia Hematologic Diseases Folic Acid Vitamin B Complex Hematinics Iron Vitamins |
Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Hematologic Agents Therapeutic Uses Trace Elements |
ClinicalTrials.gov processed this record on May 22, 2013