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

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

Study Description
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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

Study Design
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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

Arms and Interventions
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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


Outcome Measures
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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


Eligibility Criteria
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Ages Eligible for Study:   12 Years to 19 Years   (Child, Adult)
Sexes 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
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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 ClinicalTrials.gov identifier (NCT number): NCT01198574


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

Publications:

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

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Responsible Party: Min Kyaw Htet, Dr, Indonesia University
ClinicalTrials.gov 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:
anemia
iron supplementation
sub-clinical inflammation
adolescents
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes
Vitamins
Folic Acid
Vitamin A
Iron
Retinol palmitate
Micronutrients
Nutrients
Growth Substances
 Physiological Effects of Drugs
Trace Elements
Hematinics
Vitamin B Complex
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents