Deworming and Enhanced Vitamin A Every 6 Month in Rural Indian Children Aged 1-6
This study has been completed.
Sponsor:
University of Oxford
Collaborator:
United States Agency for International Development (USAID)
Information provided by:
University of Oxford
ClinicalTrials.gov Identifier:
NCT00222547
First received: September 13, 2005
Last updated: October 27, 2005
Last verified: February 2005
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | September 13, 2005 | ||||
| Last Updated Date | October 27, 2005 | ||||
| Start Date ICMJE | January 1999 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
childhood mortality rate at age 1-6 | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00222547 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
fecal egg counts, plasma retinal, growth, sign of Vitamin A deficiency | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Deworming and Enhanced Vitamin A Every 6 Month in Rural Indian Children Aged 1-6 | ||||
| Official Title ICMJE | Deworming and Enhanced Vitamin A Supplementation DEVTA Project | ||||
| Brief 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. |
||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Prevention |
||||
| Condition ICMJE | Village Children | ||||
| Intervention ICMJE |
|
||||
| Study Arm (s) | Not Provided | ||||
| Publications * |
|
||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 720000 | ||||
| Completion Date | February 2005 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | InclusionCriteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 1 Year to 6 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | India | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00222547 | ||||
| Other Study ID Numbers ICMJE | DEVTA | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | University of Oxford | ||||
| Collaborators ICMJE | United States Agency for International Development (USAID) | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | University of Oxford | ||||
| Verification Date | February 2005 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||