We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01355263
First Posted: May 18, 2011
Last Update Posted: February 20, 2013
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.
Information provided by (Responsible Party):
Ke Chen, Chengdu Maternal and Children's Health Care Hospital
  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
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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • hemoglobin [ Time Frame: 6 months ]
  • hemoglobin [ Time Frame: six months ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   2 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
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

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
First Submitted: May 9, 2011
First Posted: May 18, 2011
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:
Vitamins
Vitamin A
Iron
Retinol palmitate
Micronutrients
Growth Substances
Physiological Effects of Drugs
Trace Elements
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents


To Top