Village ChildrenPhase 4NCT00222547
Deworming and Enhanced Vitamin A Every 6 Month in Rural Indian Children Aged 1-6
A Phase 4 study testing Vitamin A and Albendazole in people with Village Children, run by University of Oxford at 1 site in India.
Trial summary
Randomisation of 72 large rural areas ("blocks") into a 2 x 2 trial of six- monthly treatment of all village children aged 1-5 with albendazole(400mg), vitamin A (200000 iu), both or neither. The placebo group get no trial treatment at all and do not receive physical placebos. Read more about this study
- Who is it for?
- Ages 1 year to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Village Children
- What is being tested?
- Vitamin A and Albendazole
- How many people
- 720,000 participants
- Where
- 1 siteIndia
- Study dates
- Jan 1999to Feb 2005
- Phase
- Phase 4
- 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 1 year to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
None listed.
Who cannot join
- NONE
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Deworming and Enhanced Vitamin A Supplementation DEVTA Project
Randomisation of 72 large rural areas ("blocks") into a 2 x 2 trial of six- monthly treatment of all village children aged 1-5 with albendazole(400mg), vitamin A (200000 iu), both or neither. The placebo group get no trial treatment at all and do not receive physical placebos.
- Conditions
- Village Children
- Being tested
- Vitamin A, Albendazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin ADrug
AlbendazoleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
childhood mortality rate at age 1-6
Secondary outcomes (1)
fecal egg counts, plasma retinal, growth, sign of Vitamin A deficiency
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJan 1999
- Study completionFeb 2005
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 Village ChildrenStudies of the same condition, open and under way.
- More trials run by University of OxfordThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 720,000 participants
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- United States Agency for International Development (USAID)
- Investigators
- Shally Awasthi, MD, Study chair, King George Medical University, Lucknow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00222547
- Sponsor's protocol ID
- DEVTA
- Status last verified
- Feb 2005
- First submitted
- 13 Sep 2005
- Last updated
- 28 Oct 2005
- Results posted
- No
Publications
Awasthi S, Peto R, Read S, Richards SM, Pande V, Bundy D; DEVTA (Deworming and Enhanced Vitamin A) team. Population deworming every 6 months with albendazole in 1 million pre-school children in North India: DEVTA, a cluster-randomised trial. Lancet. 2013 Apr 27;381(9876):1478-86. doi: 10.1016/S0140-6736(12)62126-6. Epub 2013 Mar 14.
PubMed 23498850Awasthi S, Peto R, Read S, Clark S, Pande V, Bundy D; DEVTA (Deworming and Enhanced Vitamin A) team. Vitamin A supplementation every 6 months with retinol in 1 million pre-school children in north India: DEVTA, a cluster-randomised trial. Lancet. 2013 Apr 27;381(9876):1469-77. doi: 10.1016/S0140-6736(12)62125-4. Epub 2013 Mar 14.
PubMed 23498849
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deworming and Enhanced Vitamin A Supplementation DEVTA Project
- ClinicalTrials.gov ID
- NCT00222547
- Acronym / sponsor ID
- DEVTA
- Conditions
- Village Children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 720,000 participants
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- United States Agency for International Development (USAID)
- Study start
- Jan 1999
- Study completion
- Feb 2005
- First posted
- 22 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.
Randomisation of 72 large rural areas ("blocks") into a 2 x 2 trial of six- monthly treatment of all village children aged 1-5 with albendazole(400mg), vitamin A (200000 iu), both or neither. The placebo group get no trial treatment at all and do not receive physical placebos.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- NONE
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 |
|---|---|---|
| Vitamin A | Drug | – |
| Albendazole | Drug | – |
Primary outcome
childhood mortality rate at age 1-6
1 secondary outcome
fecal egg counts, plasma retinal, growth, sign of Vitamin A deficiency
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 28 Oct 2005.
- Derived from this study: PubMed 23498850Awasthi S, Peto R, Read S, Richards SM, Pande V, Bundy D; DEVTA (Deworming and Enhanced Vitamin A) team. Population deworming every 6 months with albendazole in 1 million pre-school children in North India: DEVTA, a cluster-randomised trial. Lancet. 2013 Apr 27;381(9876):1478-86. doi: 10.1016/S0140-6736(12)62126-6. Epub 2013 Mar 14.
- Derived from this study: PubMed 23498849Awasthi S, Peto R, Read S, Clark S, Pande V, Bundy D; DEVTA (Deworming and Enhanced Vitamin A) team. Vitamin A supplementation every 6 months with retinol in 1 million pre-school children in north India: DEVTA, a cluster-randomised trial. Lancet. 2013 Apr 27;381(9876):1469-77. doi: 10.1016/S0140-6736(12)62125-4. Epub 2013 Mar 14.
Related trials for Village Children
Active, not recruiting
Regular Growth Monitoring (RGM) of Young Children in Guinea-Bissau
Severe Acute Malnutrition, Moderate Acute Malnutrition (MAM)
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.
Shally Awasthi, MD study chair
King George Medical University, Lucknow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vitamin A and Albendazole in people with Village Children, run by University of Oxford at 1 site in India.
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 0 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 28 Oct 2005. 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 India. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
childhood mortality rate at age 1-6. 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 NCT00222547, 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 28 Oct 2005.