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 of protocol
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 objectives | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Completion 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 |
| Key inclusion criteria | 1. Six to 24 months of age 2. Informed consent 3. Residing in selected communities based on geographic catchment area |
| Key exclusion criteria | 1. Haemoglobin less than 70 g/l 2. Refusal of informed consent |
| Date of first enrolment | 01/01/2004 |
| Date of final enrolment | 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 |
