Registration Dossier

Administrative data

Endpoint:
epidemiological data
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well documented publication

Data source

Reference
Reference Type:
publication
Title:
Sodium dichloroisocyanurate tablets for routine treatment of householf drinking water in periurban Ghana: A randomized controlled trial
Author:
Jain S, Sahanoon O, Blanton E, Schmitz A, Wannemuehler K, Hoekstra R & Quick R
Year:
2010
Bibliographic source:
Am. J. Trop. Med. Hyg., 82 (1) pp: 16-22

Materials and methods

Endpoint addressed:
repeated dose toxicity: oral
Principles of method if other than guideline:
A randomized, placebo-controlled, triple blinded trail to determine the health impact of daily use of sodium dichloroisocynaurate (NaDCC) tablets for household drinking water treatment was conducted in periurban Ghana.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): NaDCC tablets

Method

Type of population:
general
Details on study design:
HYPOTHESIS TESTED: The hypothesis tested was that daily use of NaDCC would improve microbiological dinking water quality and decrease individual diarrhea rates among study households



METHOD OF DATA COLLECTION
- Type: Interview



STUDY PERIOD: 12 weeks between August and November 2006


SETTING: Tamale, Ghana


STUDY POPULATION
- Selection criteria: Multifamily households with at least one child under 5 years old.
- Total number of subjects participating in study: 240 households with 3240
- Sex/age/race: 51% were female. Median age was 18 years (range 1 month to 95 years); 17% were children under 5 years old. The median age of interviewed heads of household was 367 years (range 18-74). 99% were female.



COMPARISON POPULATION
- Type: Control group
- Details: Placebo tablets


HEALTH EFFECTS STUDIED
- Diarrheal episodes were recorded each week. Each household had two visits in each calender week.
Details on exposure:
Each household received 20-L safe water storage vessel. Tablets for the intervention group were designesd to disinfect 20 L of water, contained NaDCC with a pharmaceutical/food grade effervescent base that allowed the tablets to dissolve rapidly in water, placebo tablets consited only of the effervescent base.
Statistical methods:
Data were analyzed using SAS version 9.2 (SAS institute, Cary NC).

Results and discussion

Results:
Over 12 weeks, 446 diarrhea episodes (2.2%) occurred in intervention and 404 (2.0%) in control households (P = 0.38). Residual free chlorine levels indicated appropriate tablet use. Escherichia coli was found in stored water at baseline in 96% of intervention and 88% of control households and at finalevaluation in 8% of intervention and 54% of control households (P = 0.002).

Applicant's summary and conclusion

Conclusions:
NaDCC use did not prevent diarrhea but improved water quality.