Effect of Vitamin A Supplementation on Iron Metabolic Homeostasis of Preschool Children in Sichuan,China

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01355263
Recruitment Status : Completed
First Posted : May 18, 2011
Last Update Posted : February 20, 2013
Information provided by (Responsible Party):
Ke Chen, Chengdu Maternal and Children's Health Care Hospital

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.

Condition or disease Intervention/treatment Phase
Iron Metabolic Homeostasis Drug: iron and vitamin a Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Vitamin A Supplementation on Iron Metabolic Homeostasis of Preschool Children in Sichuan,China
Study Start Date : July 2011
Actual Primary Completion Date : February 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: iron tablet, vitamin a capsule
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

Primary Outcome Measures :
  1. hemoglobin [ Time Frame: 6 months ]
  2. hemoglobin [ Time Frame: six months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • does not match the inclusion criteria

Responsible Party: Ke Chen, headmaster, Chengdu Maternal and Children's Health Care Hospital Identifier: NCT01355263     History of Changes
Other Study ID Numbers: 20090221
First Posted: May 18, 2011    Key Record Dates
Last Update Posted: February 20, 2013
Last Verified: February 2013

Keywords provided by Ke Chen, Chengdu Maternal and Children's Health Care Hospital:
vitamin a
preschool children
iron metabolic homeostasis
supplementation effect

Additional relevant MeSH terms:
Vitamin A
Retinol palmitate
Growth Substances
Physiological Effects of Drugs
Trace Elements
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents