AnemiaPhase 3NCT00148629
Treatment and Prevention of Severe Anemia in Pregnant Zanzibari Women
A Phase 3 study testing multivitamin, mebendazole in people with Anemia and Low Birth Weight, run by Cornell University at 1 site in Tanzania.
Trial summary
The purpose of this research is to compare the efficacy of two low-cost low intervention packages to prevent and treat severe anemia in pregnant women in Zanzibar, Tanzania. The two packages are Standard of Care as described by the WHO (presumptive treatment for malaria and helminths plus daily iron + folic acid… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anemia, Low Birth Weight, Neonatal Mortality
- What is being tested?
- multivitamin, mebendazole
- How many people
- 2,500 participants
- Where
- 1 siteTanzania
- Study dates
- Apr 2004to Jan 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Pregnant woman
Who cannot join
- Not a permanent resident of the community
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preventing Unnecessary Blood Transfusions in Pregnant Women in Africa Through Effective Primary Health Care
The purpose of this research is to compare the efficacy of two low-cost low intervention packages to prevent and treat severe anemia in pregnant women in Zanzibar, Tanzania. The two packages are Standard of Care as described by the WHO (presumptive treatment for malaria and helminths plus daily iron + folic acid supplements) and Enhanced Care (Standard of Care plus daily multivitamins and a 2nd dose of anthelminthic.)
Read the detailed description
This is a clinic-randomized trial involving 8 antenatal clinics and approximately 2500 women. The specific aims are:
Aim 1: To evaluate the efficacy of the current internationally recommended standard of care, as described by the WHO, for the prevention of severe anemia among pregnant Zanzibari women. This aim will be achieved through a pre-post intervention comparison.
Aim 2: To evaluate the efficacy of an enhanced treatment regimen in comparison to the current standard of care to prevent severe anemia among pregnant Zanzibari women.
Aim 3: To evaluate the efficacy of the current internationally recommended standard of care, as described by the WHO, for the cure of severe anemia among pregnant Zanzibari women.
Aim 4: To evaluate the efficacy of an enhanced treatment regimen in comparison to the current standard of care to cure severe anemia among pregnant Zanzibari women.
- Conditions
- Anemia, Low Birth Weight, Neonatal Mortality
- Being tested
- multivitamin, mebendazole
- Keywords
- Anemia, Birth weight, Neonatal Mortality, Tanzania, Pregnancy
- Medical subject headings
- Anemia, Birth Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multivitamin, mebendazoleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of severe anemia (Hb < 7 g/dL)
Cure of severe anemia
Secondary outcomes (4)
Infant birth weight
Neonatal mortality
Neonatal morbidity
Blood loss during delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startApr 2004
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,500 participants
Sponsor and investigators
- Lead sponsor
- Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, UNICEF, Johns Hopkins Bloomberg School of Public Health
- Responsible party
- Sponsor
- Investigators
- Rebecca J Stoltzfus, PhD, Principal investigator, Cornell UniversityJames M Tielsch, PhD, Principal investigator, The Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00148629
- Sponsor's protocol ID
- UCHS 02-10-030
- Status last verified
- Jan 2022
- First submitted
- 6 Sep 2005
- Last updated
- 13 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Unnecessary Blood Transfusions in Pregnant Women in Africa Through Effective Primary Health Care
- ClinicalTrials.gov ID
- NCT00148629
- Acronym / sponsor ID
- UCHS 02-10-030
- Conditions
- Anemia, Low Birth Weight, Neonatal Mortality
- Keywords
- Anemia, Birth weight, Neonatal Mortality, Tanzania, Pregnancy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,500 participants
- Lead sponsor
- Cornell UniversityUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, UNICEF, Johns Hopkins Bloomberg School of Public Health
- Study start
- Apr 2004 (actual)
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 8 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to compare the efficacy of two low-cost low intervention packages to prevent and treat severe anemia in pregnant women in Zanzibar, Tanzania. The two packages are Standard of Care as described by the WHO (presumptive treatment for malaria and helminths plus daily iron + folic acid supplements) and Enhanced Care (Standard of Care plus daily multivitamins and a 2nd dose of anthelminthic.)
Detailed description
This is a clinic-randomized trial involving 8 antenatal clinics and approximately 2500 women. The specific aims are:
Aim 1: To evaluate the efficacy of the current internationally recommended standard of care, as described by the WHO, for the prevention of severe anemia among pregnant Zanzibari women. This aim will be achieved through a pre-post intervention comparison.
Aim 2: To evaluate the efficacy of an enhanced treatment regimen in comparison to the current standard of care to prevent severe anemia among pregnant Zanzibari women.
Aim 3: To evaluate the efficacy of the current internationally recommended standard of care, as described by the WHO, for the cure of severe anemia among pregnant Zanzibari women.
Aim 4: To evaluate the efficacy of an enhanced treatment regimen in comparison to the current standard of care to cure severe anemia among pregnant Zanzibari women.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Pregnant woman
Key exclusion criteria (1 listed)
- Not a permanent resident of the community
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multivitamin, mebendazole | Drug | – |
Primary outcome
Incidence of severe anemia (Hb < 7 g/dL)
Cure of severe anemia
4 secondary outcomes
Infant birth weight
Neonatal mortality
Neonatal morbidity
Blood loss during delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca J Stoltzfus, PhD principal investigator
Cornell University
James M Tielsch, PhD principal investigator
The Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing multivitamin, mebendazole in people with Anemia and Low Birth Weight, run by Cornell University at 1 site in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of severe anemia (Hb < 7 g/dL). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.