NCT02675140

Brief Summary

The present study is intended to supplement the preschool anemic children with vitamin A capsule and de-hookworm administration in poverty Sichuan province. We eventually expect our study can provide a cost-effective, safe and more beneficial public health strategy to manage the anemia status of preschool children in poverty area.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
209

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2012

Typical duration for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 28, 2015

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 5, 2016

Completed
Last Updated

February 5, 2016

Status Verified

February 1, 2016

Enrollment Period

2.5 years

First QC Date

August 28, 2015

Last Update Submit

February 4, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin concentration

    six month

Study Arms (3)

ZENTEL

EXPERIMENTAL

Children in intervention group 1 was received 400 mg single-dose albendazole administration, by mouth, for once.

Drug: ZENTEL

ZENTEL and Vitamin A Soft Capsules

EXPERIMENTAL

Children in intervention group 2 was received a 200,000 IU vitamin A capsule combined 400 mg single-dose albendazole once initially, by mouth.

Drug: ZENTEL and Vitamin A Soft Capsules

No drug adminitrated

NO INTERVENTION

Children in this Group were received no intervention as control group

Interventions

ZENTELDRUG

Children in Group 2 (n=62) received 400 mg single-dose albendazole (helmintic treatment)

Also known as: albendazole
ZENTEL

Children in Group 3 (n=60) received a 200,000 IU vitamin A capsule combined with 400 mg single-dose albendazole once initially

Also known as: albendazole and vitamin A
ZENTEL and Vitamin A Soft Capsules

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Apparent health
  • Hb concentration \<110 g/l but not \<80 g/l
  • C-reaction protein (CRP) \<10 mg/L
  • Parental or guardian approval of participation in all aspects of the study
  • Parental/guardian agreement to avoid the additional use of vitamin and mineral supplements and de-hookworm administration during the trial.-

You may not qualify if:

  • \) Children with Hb\<80 g/l and /or CRP \>10 mg/l were sent to hospital with special treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

AnemiaHelminthiasis

Interventions

AlbendazoleVitamin A

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesParasitic DiseasesInfections

Intervention Hierarchy (Ancestors)

CarbamatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsRetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesDiterpenesPigments, BiologicalBiological Factors

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
chief

Study Record Dates

First Submitted

August 28, 2015

First Posted

February 5, 2016

Study Start

March 1, 2012

Primary Completion

September 1, 2014

Study Completion

March 1, 2015

Last Updated

February 5, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will share

It is my pleasure to share some data with other researcher who are interested in this theme.