NCT00116493

Brief Summary

The purpose of this study is to test the efficacy of two enhanced regimens (deworming and multivitamins) in the treatment of severe anemia in pregnant women and children 6-24 months of age in Karachi, Pakistan.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,009

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Apr 2004

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 29, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 30, 2005

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

April 9, 2012

Status Verified

April 1, 2012

Enrollment Period

3.1 years

First QC Date

June 29, 2005

Last Update Submit

April 6, 2012

Conditions

Anemia

Keywords

severe anemiaanthelminthicmultivitaminspregnancychildrenPakistan

Outcome Measures

Primary Outcomes (1)

  • Severe Anemia

Study Arms (4)

1

OTHER

Standard of care (Iron-folic acid + Deworming)

Dietary Supplement: Iron-folic acid and mebendazole

2

EXPERIMENTAL
Drug: Mebendazole

3

EXPERIMENTAL
Dietary Supplement: Multivitamins

4

EXPERIMENTAL
Drug: Mebendazole + Multivitamin

Interventions

Iron-folic acid and mebendazoleDIETARY_SUPPLEMENT

100 mg iron for pregnant women, 25 mg iron for children 1 mg of folic acid for pregnant women, 100 ug folic acid for children 500 mg of mebendazole for both pregnant women and children

1
MebendazoleDRUG

100 mg twice a day for 3 days; Iron-folic acid also given

2
MultivitaminsDIETARY_SUPPLEMENT

Iron-folic acid also given; Includes vitamins A, C, B12, E, and B2

3
Mebendazole + MultivitaminDRUG

Multivitamins + Mebendazole at 100 mg twice a day for 3 days; Iron-folic acid also given

4

Eligibility Criteria

Age6 Months - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Pregnant women with severe anemia (Hb\<70g/L)
  • Children 6-24 months with severe anemia (Hb\<70 g/L)

You may not qualify if:

  • Gestational age \>=36 weeks
  • Edema
  • Breathlessness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aga Khan University

Karachi, Sindh, Pakistan

Location

Related Publications (2)

  • Bhutta Z, Klemm R, Shahid F, Rizvi A, Rah JH, Christian P. Treatment response to iron and folic acid alone is the same as with multivitamins and/or anthelminthics in severely anemic 6- to 24-month-old children. J Nutr. 2009 Aug;139(8):1568-74. doi: 10.3945/jn.108.103507. Epub 2009 Jun 17.

    PMID: 19535425RESULT

  • Christian P, Shahid F, Rizvi A, Klemm RD, Bhutta ZA. Treatment response to standard of care for severe anemia in pregnant women and effect of multivitamins and enhanced anthelminthics. Am J Clin Nutr. 2009 Mar;89(3):853-61. doi: 10.3945/ajcn.2008.26826. Epub 2009 Jan 28.

    PMID: 19176737RESULT

MeSH Terms

Conditions

Anemia

Interventions

MebendazoleGeritol

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

CarbamatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Parul Christian, DrPH

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 29, 2005

First Posted

June 30, 2005

Study Start

April 1, 2004

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

April 9, 2012

Record last verified: 2012-04

Locations

PA(1)