Trial of Pre-Pregnancy Supplements

Anemia Clinical Trial

— TOPPS  

Official title:

Trial of Pre-Pregnancy Supplements

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01183572
• Other study ID #: 0055/07
• Status: Completed
• Phase: N/A
• First received: August 13, 2010
• Last updated: September 8, 2012
• Start date: August 2010
• Est. completion date: January 2012

Study information

• Verified date: September 2012
• Source: Harvard School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardTanzania: Food & Drug AdministrationTanzania: National Institute for Medical Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 802
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 29 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anemia

Intervention

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
• Folic Acid and Iron
Daily oral dose of 30 mg elemental iron, 0.4 mg folic acid
• Folic Acid
Daily oral dose of 0.4 mg folic acid

Locations

Country	Name	City	State
Tanzania	Ifakara Health Institute	Rufiji

Sponsors (2)

Lead Sponsor	Collaborator
Harvard School of Public Health	Ifakara Health Institute

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anemia	Anemia will be defined as hemoglobin < 12gm/dL at 6 months of intervention. Hemoglobin concentration will also be analyzed as a continuous outcome.	6 months following the start of the intervention	No
Secondary	Weight Gain during intervention	Weight gain during intervention will be defined as the difference in weight between weight at randomization and weight at 6 months of intervention.	6 months following the start of the intervention	No
Secondary	Mid Upper Arm Circumference		6 months following the start of the intervention	No
Secondary	Peripheral malaria parasitemia	Peripheral malaria parasitemia will be defined as fever in the past 72 hours with any malaria parasitemia in peripheral blood.	6 months following the start of the intervention	No