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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ke Chen, Chengdu Maternal and Children's Health Care Hospital
ClinicalTrials.gov Identifier:
NCT01355263
First received: May 9, 2011
Last updated: February 18, 2013
Last verified: February 2013
History of Changes
  Purpose

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 Intervention
Iron Metabolic Homeostasis
 Drug: iron and vitamin a

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Vitamin A Supplementation on Iron Metabolic Homeostasis of Preschool Children in Sichuan,China

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Chengdu Maternal and Children's Health Care Hospital:

Primary Outcome Measures:
  • hemoglobin [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • hemoglobin [ Time Frame: six months ] [ Designated as safety issue: Yes ]

Enrollment: 450
Study Start Date: July 2011
Study Completion Date: August 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   2 Years to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Ke Chen, headmaster, Chengdu Maternal and Children's Health Care Hospital
ClinicalTrials.gov Identifier: NCT01355263     History of Changes
Other Study ID Numbers: 20090221
Study First Received: May 9, 2011
Last Updated: February 18, 2013
Health Authority: China: Chengdu Hospital Authority

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

Additional relevant MeSH terms:
Vitamin A
Vitamins
Iron
Retinol palmitate
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
 Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses
Trace Elements

ClinicalTrials.gov processed this record on May 22, 2013