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

Primary Purpose

Anemia

Status
Completed
Phase
Phase 3
Locations
Myanmar
Study Type
Interventional
Intervention
Iron group
Vitamin A group
Iron and vitamin A group
Placebo group
Sponsored by
Indonesia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anemia focused on measuring anemia, iron supplementation, sub-clinical inflammation, adolescents

Eligibility Criteria

12 Years - 19 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Nyaung Done Township

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Iron group

Vitamin A group

Iron and Vitamin A group

Placebo group

Arm Description

Vitamin A group

Iron and Vitamin A group

Placebo group with folic acid

Outcomes

Primary Outcome Measures

Haemoglobin Level
Haemoglobin level (g/L) measured by cyanmethaemoglobin method
Status of Tissue Iron Store
Tissue iron store was measured by serum ferritin
Status of Cellular Iron Deficiency
Cellular Iron deficiency status is also measured by serum transferrin receptor

Secondary Outcome Measures

Full Information

First Posted
September 8, 2010
Last Updated
May 15, 2012
Sponsor
Indonesia University
Collaborators
Department of Medical Research, Lower Myanmar
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1. Study Identification

Unique Protocol Identification Number
NCT01198574
Brief Title
Sub-clinical Inflammation and Iron Supplementation
Acronym
SCI&Anaemia
Official Title
The Role of Sub-clinical Inflammation on the Iron Status of Myanmar Anaemic Adolescent Schoolgirls During Iron and Vitamin A Supplementation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University
Collaborators
Department of Medical Research, Lower Myanmar

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia
Keywords
anemia, iron supplementation, sub-clinical inflammation, adolescents

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
402 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Iron group
Arm Type
Experimental
Arm Title
Vitamin A group
Arm Type
Experimental
Arm Description
Vitamin A group
Arm Title
Iron and Vitamin A group
Arm Type
Experimental
Arm Description
Iron and Vitamin A group
Arm Title
Placebo group
Arm Type
Experimental
Arm Description
Placebo group with folic acid
Intervention Type
Dietary Supplement
Intervention Name(s)
Iron group
Other Intervention Name(s)
Iron supplement
Intervention Description
Ferrous fumarate, 60 mg, weekly dose
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin A group
Other Intervention Name(s)
Vitamin A supplement
Intervention Description
Retinol, weekly dose, 15,000 IU
Intervention Type
Dietary Supplement
Intervention Name(s)
Iron and vitamin A group
Other Intervention Name(s)
Iron and Vitamin A supplement
Intervention Description
Ferrous fumarate, Retinol combination group, weekly dose
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo group
Other Intervention Name(s)
Placebo group, folic acid only
Intervention Description
folic acid only as placebo group
Primary Outcome Measure Information:
Title
Haemoglobin Level
Description
Haemoglobin level (g/L) measured by cyanmethaemoglobin method
Time Frame
at week 0, week 6 and week12
Title
Status of Tissue Iron Store
Description
Tissue iron store was measured by serum ferritin
Time Frame
at week 0, week 6 and week12
Title
Status of Cellular Iron Deficiency
Description
Cellular Iron deficiency status is also measured by serum transferrin receptor
Time Frame
at week 0, week 6 and week12

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Min Kyaw Htet, PhD
Organizational Affiliation
(1) South East Asian Ministers of Education Organization, Regional Center for Food and Nutrition, University of Indonesia, (2) Ministry of Health, Myanmar
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nyaung Done Township
City
Pathein
State/Province
Irrawaddy Division
Country
Myanmar

12. IPD Sharing Statement

Citations:
PubMed Identifier
20610634
Citation
Thurnham DI, McCabe LD, Haldar S, Wieringa FT, Northrop-Clewes CA, McCabe GP. Adjusting plasma ferritin concentrations to remove the effects of subclinical inflammation in the assessment of iron deficiency: a meta-analysis. Am J Clin Nutr. 2010 Sep;92(3):546-55. doi: 10.3945/ajcn.2010.29284. Epub 2010 Jul 7.
Results Reference
background
PubMed Identifier
18287375
Citation
Mburu AS, Thurnham DI, Mwaniki DL, Muniu EM, Alumasa F, de Wagt A. The influence and benefits of controlling for inflammation on plasma ferritin and hemoglobin responses following a multi-micronutrient supplement in apparently healthy, HIV+ Kenyan adults. J Nutr. 2008 Mar;138(3):613-9. doi: 10.1093/jn/138.3.613.
Results Reference
background
PubMed Identifier
18177514
Citation
Thurnham DI, Mburu AS, Mwaniki DL, Muniu EM, Alumasa F, de Wagt A. Using plasma acute-phase protein concentrations to interpret nutritional biomarkers in apparently healthy HIV-1-seropositive Kenyan adults. Br J Nutr. 2008 Jul;100(1):174-82. doi: 10.1017/S0007114507883012. Epub 2008 Jan 4.
Results Reference
background
PubMed Identifier
16313694
Citation
Thurnham DI, Mburu AS, Mwaniki DL, De Wagt A. Micronutrients in childhood and the influence of subclinical inflammation. Proc Nutr Soc. 2005 Nov;64(4):502-9. doi: 10.1079/pns2005468.
Results Reference
background
PubMed Identifier
7901629
Citation
Thurnham DI. Vitamin A, iron, and haemopoiesis. Lancet. 1993 Nov 27;342(8883):1312-3. doi: 10.1016/0140-6736(93)92239-p. No abstract available.
Results Reference
background
PubMed Identifier
9209187
Citation
Angeles-Agdeppa I, Schultink W, Sastroamidjojo S, Gross R, Karyadi D. Weekly micronutrient supplementation to build iron stores in female Indonesian adolescents. Am J Clin Nutr. 1997 Jul;66(1):177-83. doi: 10.1093/ajcn/66.1.177.
Results Reference
background
PubMed Identifier
10357747
Citation
Tee ES, Kandiah M, Awin N, Chong SM, Satgunasingam N, Kamarudin L, Milani S, Dugdale AE, Viteri FE. School-administered weekly iron-folate supplements improve hemoglobin and ferritin concentrations in Malaysian adolescent girls. Am J Clin Nutr. 1999 Jun;69(6):1249-56. doi: 10.1093/ajcn/69.6.1249.
Results Reference
background
PubMed Identifier
24128336
Citation
Htet MK, Fahmida U, Dillon D, Akib A, Utomo B, Thurnham DI. The influence of vitamin A status on iron-deficiency anaemia in anaemic adolescent schoolgirls in Myanmar. Public Health Nutr. 2014 Oct;17(10):2325-32. doi: 10.1017/S1368980013002723. Epub 2013 Oct 16.
Results Reference
derived
PubMed Identifier
22705432
Citation
Htet MK, Dillon D, Akib A, Utomo B, Fahmida U, Thurnham DI. Microcytic anaemia predominates in adolescent school girls in the delta region of Myanmar. Asia Pac J Clin Nutr. 2012;21(3):411-5.
Results Reference
derived
Links:
URL
http://www.seameo-recfon.org/
Description
South East Asian Ministers of Education Organization, Regional Center for Food and Nutrition, University of Indonesia

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Sub-clinical Inflammation and Iron Supplementation

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