NCT01355263

Brief Summary

The investigators plan to perform a randomized, mutual-control and double-blinded cohort study to further exploit the vitamin A supplementation on iron metabolic homeostasis (including iron reserve, mobilization and absorption status in the same population) compared with solely iron and vitamin A plus iron.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
450

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2011

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

First Submitted

Initial submission to the registry

May 9, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 18, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

February 20, 2013

Status Verified

February 1, 2013

Enrollment Period

7 months

First QC Date

May 9, 2011

Last Update Submit

February 18, 2013

Conditions

Iron Metabolic Homeostasis

Keywords

vitamin apreschool childreniron metabolic homeostasissupplementation effect

Outcome Measures

Primary Outcomes (2)

  • hemoglobin

    6 months

  • hemoglobin

    six months

Study Arms (1)

iron tablet, vitamin a capsule

EXPERIMENTAL

children in Group I received a 200,000 IU vitamin A capsule just one time initially; Group II received ferrous sulfate (element Fe 1-2 mg/kg•day) once a day for 6 months;.

Drug: iron and vitamin a

Interventions

iron and vitamin aDRUG
iron tablet, vitamin a capsule

Eligibility Criteria

Age2 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • apparent health;
  • Hb concentration\>60 g/L;
  • C-reaction protein (CRP)\<10 mg/L;
  • parental or guardian approval of participation in all aspects of the study; and
  • parental/guardian agreement to avoid the additional use of vitamin and mineral supplements during the investigation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

IronVitamin A

Intervention Hierarchy (Ancestors)

Metals, HeavyElementsInorganic ChemicalsTransition ElementsMetalsRetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesDiterpenesPigments, BiologicalBiological Factors

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
headmaster

Study Record Dates

First Submitted

May 9, 2011

First Posted

May 18, 2011

Study Start

July 1, 2011

Primary Completion

February 1, 2012

Study Completion

August 1, 2012

Last Updated

February 20, 2013

Record last verified: 2013-02