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

This study has been completed.
Department of Medical Research, Lower Myanmar
Information provided by (Responsible Party):
Min Kyaw Htet, Indonesia University Identifier:
First received: September 8, 2010
Last updated: May 15, 2012
Last verified: May 2012
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
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:

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


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

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
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Please refer to this study by its identifier: NCT01198574

Nyaung Done Township
Pathein, Irrawaddy Division, Myanmar
Sponsors and Collaborators
Indonesia University
Department of Medical Research, Lower Myanmar
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:

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Min Kyaw Htet, Dr, Indonesia University 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:
iron supplementation
sub-clinical inflammation

Additional relevant MeSH terms:
Pathologic Processes
Folic Acid
Retinol palmitate
Vitamin A
Vitamin B Complex
Anticarcinogenic Agents
Antineoplastic Agents
Growth Substances
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses
Trace Elements processed this record on November 27, 2015