Xylitol for healthy teeth and ears project
| ISRCTN | ISRCTN84269958 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84269958 |
| Protocol serial number | R40 MC03622 |
| Sponsor | University of Washington (USA) |
| Funder | Maternal and Child Health Bureau - Health Resources and Services Administration (MCHB - HRSA) (USA) |
- Submission date
- 07/02/2008
- Registration date
- 26/02/2008
- Last edited
- 31/08/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Peter Milgrom
Scientific
Scientific
Dental Public Health Sciences
1959 NE Pacific Street
Rm B-509
Box 357475
Seattle
98195
United States of America
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Xylitol for acute otitis media and early childhood caries |
| Study objectives | Xylitol syrup reduces the incidence of dental caries and acute otitis media |
| Ethics approval(s) | University of Washington Institutional Review Board, initial approval granted on 19 July 2005 (ref: HSD# 04-4039-B 01). The approval has been renewed annually on 17 August 2006 (ref: HSD# 04-4039-B 02) and 12 August 2007 (ref:HSD# 04-4039-B 03). |
| Health condition(s) or problem(s) studied | Dental caries and acute otitis media |
| Intervention | Three group design: 1. Xylitol syrup 8 g/day divided into 2 doses + 1 dose of sorbitol = 3 doses/day 2. Xylitol syrup 8 g/day divided into 3 doses + 0 dose of sorbitol = 3 doses/day 3. Xylitol syrup 2.66 g/day in a single dose (positive control) + 2 doses of sorbitol = 3 doses/day Duration of interventions: 12 months |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Xylitol |
| Primary outcome measure(s) | 1. Dental caries, assessed at baseline (at randomization), mid study (5-6 months), and 12 months (end of study period) 2. Acute otitis media (incidence rate). Children were assessed as symptoms suggestive of acute otitis media arose throughout the follow-up period (12 months) |
| Key secondary outcome measure(s) | No secondary outcome measures |
| Completion date | 15/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Months |
| Upper age limit | 15 Months |
| Sex | All |
| Target sample size at registration | 102 |
| Key inclusion criteria | Children aged 6-15 months of age living in Laura or Delap district of Majuro Atoll, the Marshall Islands |
| Key exclusion criteria | Children with known gastrointestinal problems |
| Date of first enrolment | 01/04/2006 |
| Date of final enrolment | 15/01/2008 |
Locations
Countries of recruitment
- Marshall Islands
- United States of America
Study participating centre
Dental Public Health Sciences
Seattle
98195
United States of America
98195
United States of America
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2009 | Yes | No |
