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

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: NCT01198574
Recruitment Status : Completed
First Posted : September 10, 2010
Results First Posted : May 16, 2012
Last Update Posted : May 22, 2012
Department of Medical Research, Lower Myanmar
Information provided by (Responsible Party):
Min Kyaw Htet, Indonesia University

Brief Summary:
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 or disease Intervention/treatment Phase
Anemia Dietary Supplement: Iron group Dietary Supplement: Vitamin A group Dietary Supplement: Iron and vitamin A group Dietary Supplement: Placebo group Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 402 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : July 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron Vitamin A

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Haemoglobin Level [ Time Frame: at week 0, week 6 and week12 ]
    Haemoglobin level (g/L) measured by cyanmethaemoglobin method

  2. Status of Tissue Iron Store [ Time Frame: at week 0, week 6 and week12 ]
    Tissue iron store was measured by serum ferritin

  3. Status of Cellular Iron Deficiency [ Time Frame: at week 0, week 6 and week12 ]
    Cellular Iron deficiency status is also measured by serum transferrin receptor

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 19 Years   (Child, Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01198574

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Min Kyaw Htet, Dr, Indonesia University Identifier: NCT01198574    
Other Study ID Numbers: SCIVA
First Posted: September 10, 2010    Key Record Dates
Results First Posted: May 16, 2012
Last Update Posted: May 22, 2012
Last Verified: May 2012
Keywords provided by Min Kyaw Htet, Indonesia University:
iron supplementation
sub-clinical inflammation
Additional relevant MeSH terms:
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Pathologic Processes
Folic Acid
Vitamin A
Retinol palmitate
Growth Substances
Physiological Effects of Drugs
Trace Elements
Vitamin B Complex
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents