Effects of intestinal helminth infections in early childhood on immune response, inflammation, anaemia and malnutrition
| ISRCTN | ISRCTN83988447 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83988447 |
| Secondary identifying numbers | 063122 |
- Submission date
- 22/07/2005
- Registration date
- 22/07/2005
- Last edited
- 13/12/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Haematological Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Not provided at time of registration
Contact information
Ms Rebecca J Stoltzfus
Scientific
Scientific
Cornell University
Division of Nutritional Sciences
120 Savage Hall
Ithaca NY
14853
United States of America
| Phone | +1 607 255 7671 |
|---|---|
| rjs62@cornell.edu |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study hypothesis | To test whether anthelminthic treatment of children six to 36 months of age decreases severe anaemia, decreases wasting malnutrition, and decreases anorexia. |
| Ethics approval(s) | Not provided at time of registration |
| Condition | Anaemia, protein-energy malnutrition, anorexia |
| Intervention | Double blind Randomised Controlled Trial (RCT) of mebendazole versus an identical-looking but inert placebo. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Mebendazole |
| Primary outcome measure | 1. Haemoglobin less than 70 g/l 2. Mid upper arm circumference less than -2 Z scores of international reference 3. Maternal report of anorexia |
| Secondary outcome measures | 1. Weight-for-height less than -1 Z scores of international reference 2. Height-for-age less than -2 Z scores on international reference 3. Inflammation |
| Overall study start date | 01/01/2004 |
| Overall study end date | 31/03/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Months |
| Upper age limit | 24 Months |
| Sex | Both |
| Target number of participants | 2500 |
| Participant inclusion criteria | 1. Six to 24 months of age 2. Informed consent 3. Residing in selected communities based on geographic catchment area |
| Participant exclusion criteria | 1. Haemoglobin less than 70 g/l 2. Refusal of informed consent |
| Recruitment start date | 01/01/2004 |
| Recruitment end date | 31/03/2006 |
Locations
Countries of recruitment
- Tanzania
- United States of America
Study participating centre
Cornell University
Ithaca NY
14853
United States of America
14853
United States of America
Sponsor information
Cornell University (USA)
University/education
University/education
Division of Nutritional Sciences
Ithaca, NY
14853
United States of America
| Phone | +1 607 255 2946 |
|---|---|
| crf1@cornell.edu | |
| Website | http://www.cornell.edu/ |
"ROR" |
https://ror.org/05bnh6r87 |
Funders
Funder type
Charity
The Wellcome Trust (UK) (grant ref: 063122)
No information available
Burroughs Wellcome Initiative (USA)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
