Anemia
Conditions
Keywords
multivitamins, folate, iron, periconception
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.
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.
Interventions
DIETARY_SUPPLEMENTMultivitamins, 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
DIETARY_SUPPLEMENTFolic Acid and Iron
Daily oral dose of 30 mg elemental iron, 0.4 mg folic acid
DIETARY_SUPPLEMENTFolic Acid
Daily oral dose of 0.4 mg folic acid
Sponsors
Ifakara Health Institute
Harvard School of Public Health (HSPH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 29 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anemia | 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
| Measure | Time frame | Description |
|---|---|---|
| Weight Gain during intervention | 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. |
| Mid Upper Arm Circumference | 6 months following the start of the intervention | — |
| Peripheral malaria parasitemia | 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. |
Countries
Tanzania
Outcome results
None listed