Status:

COMPLETED

Trial of Pre-Pregnancy Supplements

Lead Sponsor:

Harvard School of Public Health (HSPH)

Collaborating Sponsors:

Ifakara Health Institute

Conditions:

Anemia

Eligibility:

FEMALE

15-29 years

Phase:

NA

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 ...

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...

Eligibility Criteria

Inclusion

  • 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

  • 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).

Key Trial Info

Start Date :

August 1 2010

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2012

Estimated Enrollment :

802 Patients enrolled

Trial Details

Trial ID

NCT01183572

Start Date

August 1 2010

End Date

January 1 2012

Last Update

September 11 2012

Active Locations (1)

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Ifakara Health Institute

Rufiji, Tanzania