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Sub-clinical Inflammation and Iron Supplementation

Information source: Indonesia University
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Anemia

Intervention: Iron group (Dietary Supplement); Vitamin A group (Dietary Supplement); Iron and vitamin A group (Dietary Supplement); Placebo group (Dietary Supplement)

Phase: Phase 3

Status: Completed

Sponsored by: Indonesia University

Official(s) and/or principal investigator(s):
Min Kyaw Htet, PhD, Principal Investigator, Affiliation: (1) South East Asian Ministers of Education Organization, Regional Center for Food and Nutrition, University of Indonesia, (2) Ministry of Health, Myanmar

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.

Clinical Details

Official title: The Role of Sub-clinical Inflammation on the Iron Status of Myanmar Anaemic Adolescent Schoolgirls During Iron and Vitamin A Supplementation

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome:

Haemoglobin Level

Status of Tissue Iron Store

Status of Cellular Iron Deficiency

Eligibility

Minimum age: 12 Years. Maximum age: 19 Years. Gender(s): Female.

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

Locations and Contacts

Nyaung Done Township, Pathein, Irrawaddy Division, Myanmar
Additional Information

South East Asian Ministers of Education Organization, Regional Center for Food and Nutrition, University of Indonesia

Related publications:

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.

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.

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.

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. Review.

Thurnham DI. Vitamin A, iron, and haemopoiesis. Lancet. 1993 Nov 27;342(8883):1312-3.

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.

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.

Starting date: July 2010
Last updated: May 15, 2012

Page last updated: August 20, 2015

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