Ignite Creation Date:
2025-12-26 @ 12:16 PM
Ignite Modification Date:
2025-12-26 @ 12:16 PM
Study NCT ID:
NCT00396500
Status:
COMPLETED
Last Update Posted:
2006-11-07
First Post:
2006-11-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Deworming and Vitamin A (DEVTA) Prepilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D014201', 'term': 'Trematode Infections'}], 'ancestors': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D006373', 'term': 'Helminthiasis'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015766', 'term': 'Albendazole'}, {'id': 'D014801', 'term': 'Vitamin A'}], 'ancestors': [{'id': 'D002219', 'term': 'Carbamates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D012176', 'term': 'Retinoids'}, {'id': 'D002338', 'term': 'Carotenoids'}, {'id': 'D011090', 'term': 'Polyenes'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D053138', 'term': 'Cyclohexenes'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D010860', 'term': 'Pigments, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 4000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1994-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-11', 'completionDateStruct': {'date': '1996-12'}, 'lastUpdateSubmitDate': '2006-11-06', 'studyFirstSubmitDate': '2006-11-04', 'studyFirstSubmitQcDate': '2006-11-06', 'lastUpdatePostDateStruct': {'date': '2006-11-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-11-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in weight in 2 years'}], 'secondaryOutcomes': [{'measure': 'Secondary: Weight and Height gain in underweight, stunted and wasted children'}]}, 'conditionsModule': {'keywords': ['Deworming', 'Malnutrition', 'children', 'Community', 'India'], 'conditions': ['Malnutrition', 'Worm Infestation', 'Under-Fives']}, 'referencesModule': {'references': [{'pmid': '18414647', 'type': 'DERIVED', 'citation': 'Awasthi S, Peto R, Pande VK, Fletcher RH, Read S, Bundy DA. Effects of deworming on malnourished preschool children in India: an open-labelled, cluster-randomized trial. PLoS Negl Trop Dis. 2008 Apr 16;2(4):e223. doi: 10.1371/journal.pntd.0000223.'}]}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Local residents\n* Aged 1-5 years\n* Informed written parental consent\n\nExclusion Criteria:\n\n* Refusal to give consent\n* prior enrollment in the study'}, 'identificationModule': {'nctId': 'NCT00396500', 'briefTitle': 'Deworming and Vitamin A (DEVTA) Prepilot Study', 'organization': {'class': 'OTHER', 'fullName': "King George's Medical University"}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Albendazole (400 mg) and/or Vitamin a', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '226003', 'city': 'Lucknow', 'state': 'Uttar Pradesh', 'country': 'India', 'facility': 'Lucknow Commission', 'geoPoint': {'lat': 26.83928, 'lon': 80.92313}}], 'overallOfficials': [{'name': 'Shally Awasthi, MD, DNB', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Dept of Pediatrics, King George's Medical University, Lucknow, India"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "King George's Medical University", 'class': 'OTHER'}, 'collaborators': [{'name': 'United States Agency for International Development (USAID)', 'class': 'FED'}]}}}