This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback
Trial record 1 of 1 for:    NCT00396500
Previous Study | Return to List | Next Study

Deworming and Vitamin A (DEVTA) Prepilot Study

This study has been completed.
United States Agency for International Development (USAID)
Information provided by:
King George's Medical University Identifier:
First received: November 4, 2006
Last updated: November 6, 2006
Last verified: November 2006
Background. More than a third of the world’s population is infected with intestinal nematodes. A majority of these infections occur in children. Current control approaches emphasise treatment of school age children, and there is a lack of information on the effects of deworming preschool childrenSetting: Within the Integrated Child Development System (ICDS) infrastructure in urban Lucknow (UP), IndiaDesign: Open Labeled randomised trialHypothesis: Our study hypothesis was that albendazole administration six monthly, as a single 400 mg dose in syrup, by the existing health care delivery system would be a practicable way to achieve mass deworming of preschool children and this might result in an improvement in weight gain of preschool childrenIntervention One group will receive usual health care by the existing health care staff, which included six monthly administration of Vitamin A concentrate. The other group will receive, in addition, 400 mg of albendazole (Zentel, Smith Kline & Beecham) in 10 ml syrup form. Five such doses will be given at six monthly intervals for 2 years.Main objective: To assess the impact of 6 monthly deworming on weight and height gain at the end of 2 years in children aged 1 to 5 years of age Main outcomes measures: Weight gain in 2 yearsInclusion criteria: Children 1 to 5 years, whose guardians give written informed consent. Exclusion criteria: Those not consentingSample size: Sample size was calculated for a continuous outcome. For a standardized effect size of 0.1, with a power of 80% and an alpha level of 0.05, using a 2-tailed t test, taking into account design effect, about 2000 children will be included in each arm.

Condition Intervention Phase
Malnutrition Worm Infestation Under-Fives Drug: Albendazole (400 mg) and/or Vitamin a Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: To Assess the Effectiveness of Six-Monthly Deworming With Vitamin A Administration on Growth in 1-5 Year Old Children in the Urban Slums of Lucknow

Resource links provided by NLM:

Further study details as provided by King George's Medical University:

Primary Outcome Measures:
  • Change in weight in 2 years

Secondary Outcome Measures:
  • Secondary: Weight and Height gain in underweight, stunted and wasted children

Estimated Enrollment: 4000
Study Start Date: April 1994
Estimated Study Completion Date: December 1996

Ages Eligible for Study:   1 Year to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Local residents
  • Aged 1-5 years
  • Informed written parental consent

Exclusion Criteria:

  • Refusal to give consent
  • prior enrollment in the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00396500

Lucknow Commission
Lucknow, Uttar Pradesh, India, 226003
Sponsors and Collaborators
King George's Medical University
United States Agency for International Development (USAID)
Principal Investigator: Shally Awasthi, MD, DNB Dept of Pediatrics, King George's Medical University, Lucknow, India
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00396500     History of Changes
Other Study ID Numbers: 01
Study First Received: November 4, 2006
Last Updated: November 6, 2006

Keywords provided by King George's Medical University:

Additional relevant MeSH terms:
Parasitic Diseases
Nutrition Disorders
Vitamin A
Retinol palmitate
Growth Substances
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents
Antiparasitic Agents
Anti-Infective Agents
Anticestodal Agents
Antiplatyhelmintic Agents
Antiprotozoal Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators processed this record on September 21, 2017