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
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