Deworming and Enhanced Vitamin A Every 6 Month in Rural Indian Children Aged 1-6

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

720000 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-01-31

Study Completion Date

2005-02-28

Brief Summary

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Randomisation of 72 large rural areas ("blocks") into a 2 x 2 trial of six- monthly treatment of all village children aged 1-5 with albendazole(400mg), vitamin A (200000 iu), both or neither. The placebo group get no trial treatment at all and do not receive physical placebos.

Detailed Description

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Conditions

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Village Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Vitamin A

Intervention Type DRUG

Albendazole

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Area of residence

Exclusion Criteria

* NONE

Minimum Eligible Age

1 Year

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Principal Investigators

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Shally Awasthi, MD

Role: STUDY_CHAIR

King George Medical University, Lucknow

Locations

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Shally Awasthi

Lucknow, Uttar Pradesh, India

Site Status

Countries

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India

References

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Awasthi S, Peto R, Read S, Richards SM, Pande V, Bundy D; DEVTA (Deworming and Enhanced Vitamin A) team. Population deworming every 6 months with albendazole in 1 million pre-school children in North India: DEVTA, a cluster-randomised trial. Lancet. 2013 Apr 27;381(9876):1478-86. doi: 10.1016/S0140-6736(12)62126-6. Epub 2013 Mar 14.

Reference Type DERIVED

PMID: 23498850 (View on PubMed)

Awasthi S, Peto R, Read S, Clark S, Pande V, Bundy D; DEVTA (Deworming and Enhanced Vitamin A) team. Vitamin A supplementation every 6 months with retinol in 1 million pre-school children in north India: DEVTA, a cluster-randomised trial. Lancet. 2013 Apr 27;381(9876):1469-77. doi: 10.1016/S0140-6736(12)62125-4. Epub 2013 Mar 14.