MalnutritionPhase 3NCT00396500
Deworming and Vitamin A (DEVTA) Prepilot Study
A Phase 3 study testing Albendazole (400 mg) and/or Vitamin a in people with Malnutrition and Worm Infestation, run by King George's Medical University at 1 site in India.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 1 year to 5 years
- Conditions the study is for
- Malnutrition, Worm Infestation, Under-Fives
- What is being tested?
- Albendazole (400 mg) and/or Vitamin a
- How many people
- 4,000 participants
- Where
- 1 siteIndia
- Study dates
- Apr 1994to Dec 1996
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Local residents
- Aged 1-5 years
- Informed written parental consent
Who cannot join
- Refusal to give consent
- prior enrollment in the study
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Malnutrition, Worm Infestation, Under-Fives
- Being tested
- Albendazole (400 mg) and/or Vitamin a
- Keywords
- Deworming, Malnutrition, children, Community, India
- Medical subject headings
- Malnutrition, Trematode Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Albendazole (400 mg) and/or Vitamin aDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weight in 2 years
Secondary outcomes (1)
Secondary: Weight and Height gain in underweight, stunted and wasted children
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2006 (estimated)
- Study startApr 1994
- Study completionDec 1996
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4,000 participants
Sponsor and investigators
- Lead sponsor
- King George's Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Agency for International Development (USAID)
- Investigators
- Shally Awasthi, MD, DNB, Principal investigator, Dept of Pediatrics, King George's Medical University, Lucknow, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00396500
- Sponsor's protocol ID
- 01
- Status last verified
- Nov 2006
- First submitted
- 4 Nov 2006
- Last updated
- 7 Nov 2006
- Results posted
- No
Publications
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.
PubMed 18414647
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00396500
- Acronym / sponsor ID
- 01
- Conditions
- Malnutrition, Worm Infestation, Under-Fives
- Keywords
- Deworming, Malnutrition, children, Community, India
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,000 participants
- Lead sponsor
- King George's Medical UniversityUniversity, hospital or other
- Collaborators
- United States Agency for International Development (USAID)
- Study start
- Apr 1994
- Study completion
- Dec 1996
- First posted
- 7 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Local residents
- Aged 1-5 years
- Informed written parental consent
Key exclusion criteria (2 listed)
- Refusal to give consent
- prior enrollment in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Albendazole (400 mg) and/or Vitamin a | Drug | – |
Primary outcome
Change in weight in 2 years
1 secondary outcome
Secondary: Weight and Height gain in underweight, stunted and wasted children
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2006.
- Derived from this study: PubMed 18414647Awasthi 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.
Related trials for Malnutrition
Not yet recruitingObservational study
Prognostic Value of Functional-Nutritional Status in Older Adults With Acute Coronary Syndrome
Acute Coronary Syndromes (ACS)
RecruitingObservational study
Clinical and Laboratory Study of Methylmalonic Acidemia
Organic Acidemia, Methylmalonic Acidemia
Not yet recruiting
SHIFT-TB: Nutrition Intervention and Evaluation
Underweight, Overweight and Obesity
Not yet recruiting
Efficacy of MAGNESIO TOTAL on Sleep Quality and Quality of Life in Adults
Sleep Quality, Magnesium Deficiency
RecruitingObservational study
A Natural History Study of Bone and Mineral Disorders
Tumor Induced Osteomalcia, Osteomalacia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shally Awasthi, MD, DNB principal investigator
Dept of Pediatrics, King George's Medical University, Lucknow, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Albendazole (400 mg) and/or Vitamin a in people with Malnutrition and Worm Infestation, run by King George's Medical University at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in weight in 2 years. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00396500, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2006.