Ifakara Health Institute
Rufiji, Tanzania
NCT Number: NCT01183572
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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Notify Me15 year–29 year
Female
Interventional
Not applicable
Rufiji, Tanzania
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Daily oral dose of 30 mg elemental iron, 0.4 mg folic acid
Daily oral dose of 0.4 mg folic acid
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.
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.
Time frame: 6 months following the start of the intervention
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.
Harvard School of Public Health (HSPH)
Other
Acronym: TOPPS
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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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