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Sub-clinical Inflammation and Iron Supplementation (SCI&Anaemia)

This study has been completed.
Sponsor:
Collaborator:
Nutrition Research Division, Department of Medical Research (Lower Myanmar)
Information provided by (Responsible Party):
Min Kyaw Htet, Indonesia University
ClinicalTrials.gov Identifier:
NCT01198574
First received: September 8, 2010
Last updated: May 15, 2012
Last verified: May 2012
History of Changes
  Purpose

Anemia and vitamin A deficiency (VAD) are major nutritional problems in the world and also in Myanmar. Both nutrient deficiencies result from interaction of several causal factors, and a better understanding of the etiology to interpret the prevalence and to formulate appropriate measures to reduce these deficiencies is necessary. There is a growing concern on the role of sub-clinical inflammation on the nutritional status indicators during the nutritional status assessment. However, there is lack of information on the role of inflammation on the iron supplementation. The adolescent period is a window of opportunity to improve the preconceptional iron status of the girls and recently gained much attention. The purpose of the study is to understand the role of inflammation on iron and vitamin A status during iron and vitamin A supplementation. The findings will show the extent to which iron supplementation has been hampered by inflammation and to formulate the necessary measures to overcome the interference.


Condition Intervention Phase
Anemia
 Dietary Supplement: Iron group
Dietary Supplement: Vitamin A group
Dietary Supplement: Iron and vitamin A group
Dietary Supplement: Placebo group
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Role of Sub-clinical Inflammation on the Iron Status of Myanmar Anaemic Adolescent Schoolgirls During Iron and Vitamin A Supplementation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Indonesia University:

Primary Outcome Measures:
  • Haemoglobin Level [ Time Frame: at week 0, week 6 and week12 ] [ Designated as safety issue: No ]
    Haemoglobin level (g/L) measured by cyanmethaemoglobin method

  • Status of Tissue Iron Store [ Time Frame: at week 0, week 6 and week12 ] [ Designated as safety issue: No ]
    Tissue iron store was measured by serum ferritin

  • Status of Cellular Iron Deficiency [ Time Frame: at week 0, week 6 and week12 ] [ Designated as safety issue: No ]
    Cellular Iron deficiency status is also measured by serum transferrin receptor


Enrollment: 402
Study Start Date: July 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Iron group Dietary Supplement: Iron group
Ferrous fumarate, 60 mg, weekly dose
Other Name: Iron supplement
Experimental: Vitamin A group
Vitamin A group
 Dietary Supplement: Vitamin A group
Retinol, weekly dose, 15,000 IU
Other Name: Vitamin A supplement
Experimental: Iron and Vitamin A group
Iron and Vitamin A group
 Dietary Supplement: Iron and vitamin A group
Ferrous fumarate, Retinol combination group, weekly dose
Other Name: Iron and Vitamin A supplement
Experimental: Placebo group
Placebo group with folic acid
 Dietary Supplement: Placebo group
folic acid only as placebo group
Other Name: Placebo group, folic acid only

  Eligibility

Ages Eligible for Study:   12 Years to 19 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • adolescent girls (age 12-19 years)
  • already experienced menarche
  • anemic girls (Hb<120 g/L)
  • no known illness (apparently healthy)
  • free from haemoglobinopathy
  • No regular consumption of iron and vitamin A supplement during the last 3 months

Exclusion Criteria:

  • subjects with chronic illness
  • subjects with severe anaemia
  • who do not give the consents
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01198574

Locations
Myanmar
Nyaung Done Township
Pathein, Irrawaddy Division, Myanmar
Sponsors and Collaborators
Indonesia University
Nutrition Research Division, Department of Medical Research (Lower Myanmar)
Investigators
Principal Investigator: Min Kyaw Htet, PhD (1) South East Asian Ministers of Education Organization, Regional Center for Food and Nutrition, University of Indonesia, (2) Ministry of Health, Myanmar
  More Information

Additional Information:
South East Asian Ministers of Education Organization, Regional Center for Food and Nutrition, University of Indonesia  This link exits the ClinicalTrials.gov site

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Min Kyaw Htet, Dr, Indonesia University
ClinicalTrials.gov Identifier: NCT01198574     History of Changes
Other Study ID Numbers: SCIVA
Study First Received: September 8, 2010
Results First Received: December 31, 2011
Last Updated: May 15, 2012
Health Authority: Myanmar:Department of Medical Research, Lower Myanmar.

Keywords provided by Indonesia University:
anemia
iron supplementation
sub-clinical inflammation
adolescents

Additional relevant MeSH terms:
Anemia
Inflammation
Hematologic Diseases
Pathologic Processes
Folic Acid
Vitamin B Complex
Vitamin A
Iron
Vitamins
Retinol palmitate
Micronutrients
Growth Substances
 Physiological Effects of Drugs
Pharmacologic Actions
Hematinics
Hematologic Agents
Therapeutic Uses
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents
Trace Elements

ClinicalTrials.gov processed this record on May 23, 2013