AnemiaPhase 3NCT00116493
Severe Anemia Treatment Trials, Pakistan
A Phase 3 study testing Iron-folic acid and mebendazole, Mebendazole and Multivitamins in people with Anemia, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 45 years
- Conditions the study is for
- Anemia
- What is being tested?
- Iron-folic acid and mebendazole, Mebendazole and Multivitamins
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,009 participants
- Where
- 1 sitePakistan
- Study dates
- Apr 2004to May 2007
- 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 6 months to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pregnant women with severe anemia (Hb<70g/L)
- Children 6-24 months with severe anemia (Hb<70 g/L)
Who cannot join
- Gestational age >=36 weeks
- Edema
- Breathlessness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Anthelminthics and Multivitamins for Treatment of Severe Anemia in Pregnant Women and Children 6-24 Months of Age in Pakistan
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.
Read the detailed description
Anemia continues to be a public health problem of global proportions. Severe anemia (hemoglobin, Hb< 70 g/L) is of special concern as it poses a significant health and mortality risk. Pregnant women and young children (6-24 months of age) are the two groups at highest risk. Severe anemia in pregnant women is associated with an elevated risk of maternal and perinatal mortality as well as case fatality. Pakistan, the country in which this study is ongoing, may harbor the highest prevalence of severe anemia in South Asia, with as high as 15% being reported among pregnant women. Comparable rates (11-12%) are also seen among 6-24 month old children. Iron deficiency is one of the major causes of anemia in young children and pregnant women in South Asia. In addition to iron, deficiency of vitamins such as folic acid, vitamin A, vitamin C, riboflavin and vitamin E can also inhibit erythropoiesis. Apart from these nutritional causes, two other infectious causes of severe anemia are malaria and geohelminths. The current international recommendation for treatment of anemia includes iron and folic acid but not other vitamins.
Comparisons: Severely anemic pregnant women and children 6-24 months are randomized to receive enhanced treatment of deworming and multivitamins over and above the standard of care of iron-folic acid using a 2x2 factorial design.
- Conditions
- Anemia
- Being tested
- Iron-folic acid and mebendazole, Mebendazole, Multivitamins, Mebendazole + Multivitamin
- Keywords
- severe anemia, anthelminthic, multivitamins, pregnancy, children, Pakistan
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
MebendazoleDrug
100 mg twice a day for 3 days; Iron-folic acid also given
MultivitaminsDietary supplement
Iron-folic acid also given; Includes vitamins A, C, B12, E, and B2
Mebendazole + MultivitaminDrug
Multivitamins + Mebendazole at 100 mg twice a day for 3 days; Iron-folic acid also given
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Standard of care (Iron-folic acid + Deworming) Receives: Dietary Supplement: Iron-folic acid and mebendazole |
| 2 | Experimental | Not described Receives: Drug: Mebendazole |
| 3 | Experimental | Not described Receives: Dietary Supplement: Multivitamins |
| 4 | Experimental | Not described Receives: Drug: Mebendazole + Multivitamin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severe Anemia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2005 (estimated)
- Study startApr 2004
- Primary completionMay 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,009 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Aga Khan University
- Responsible party
- Principal investigator, Parul Christian, Johns Hopkins Bloomberg School of Public Health
- Investigators
- Parul Christian, DrPH, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00116493
- Sponsor's protocol ID
- H.22.03.04.22.A2
- Other IDs
- Thrasher Research Fund 02817-9
- Status last verified
- Apr 2012
- First submitted
- 29 Jun 2005
- Last updated
- 9 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19535425Christian 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.
PubMed 19176737
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Anthelminthics and Multivitamins for Treatment of Severe Anemia in Pregnant Women and Children 6-24 Months of Age in Pakistan
- ClinicalTrials.gov ID
- NCT00116493
- Acronym / sponsor ID
- H.22.03.04.22.A2
- Conditions
- Anemia
- Keywords
- severe anemia, anthelminthic, multivitamins, pregnancy, children, Pakistan
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,009 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- Aga Khan University
- Study start
- Apr 2004
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 30 Jun 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 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.
Detailed description
Anemia continues to be a public health problem of global proportions. Severe anemia (hemoglobin, Hb< 70 g/L) is of special concern as it poses a significant health and mortality risk. Pregnant women and young children (6-24 months of age) are the two groups at highest risk. Severe anemia in pregnant women is associated with an elevated risk of maternal and perinatal mortality as well as case fatality. Pakistan, the country in which this study is ongoing, may harbor the highest prevalence of severe anemia in South Asia, with as high as 15% being reported among pregnant women. Comparable rates (11-12%) are also seen among 6-24 month old children. Iron deficiency is one of the major causes of anemia in young children and pregnant women in South Asia. In addition to iron, deficiency of vitamins such as folic acid, vitamin A, vitamin C, riboflavin and vitamin E can also inhibit erythropoiesis. Apart from these nutritional causes, two other infectious causes of severe anemia are malaria and geohelminths. The current international recommendation for treatment of anemia includes iron and folic acid but not other vitamins.
Comparisons: Severely anemic pregnant women and children 6-24 months are randomized to receive enhanced treatment of deworming and multivitamins over and above the standard of care of iron-folic acid using a 2x2 factorial design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Dietary Supplement: Iron-folic acid and mebendazoleStandard of care (Iron-folic acid + Deworming) |
| 2 | Experimental | Drug: Mebendazole |
| 3 | Experimental | Dietary Supplement: Multivitamins |
| 4 | Experimental | Drug: Mebendazole + Multivitamin |
Who may qualify
- Ages
- 6 months to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Pregnant women with severe anemia (Hb<70g/L)
- Children 6-24 months with severe anemia (Hb<70 g/L)
Key exclusion criteria (3 listed)
- Gestational age >=36 weeks
- Edema
- Breathlessness
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 |
|---|---|---|
| Iron-folic acid and mebendazole100 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 | Dietary supplement | 1 |
| Mebendazole100 mg twice a day for 3 days; Iron-folic acid also given | Drug | 2 |
| MultivitaminsIron-folic acid also given; Includes vitamins A, C, B12, E, and B2 | Dietary supplement | 3 |
| Mebendazole + MultivitaminMultivitamins + Mebendazole at 100 mg twice a day for 3 days; Iron-folic acid also given | Drug | 4 |
Primary outcome
Severe Anemia
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 9 Apr 2012.
- Results publication: PubMed 19535425Bhutta 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.
- Results publication: PubMed 19176737Christian 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.
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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.
Parul Christian, DrPH principal investigator
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 Iron-folic acid and mebendazole, Mebendazole and Multivitamins in people with Anemia, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Pakistan.
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 2 inclusion and 3 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 9 Apr 2012. 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 Pakistan. 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?
Severe Anemia. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00116493, which also lists 2 linked publications.
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 9 Apr 2012.