Clinical trial NCT01198574: Sub-clinical Inflammation and Iron Supplementation
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Keywords: anemia
iron supplementation
sub-clinical inflammation
adolescents
Lead sponsor: Indonesia University
Sponsor class: OTHER
Collaborators: name: Department of Medical Research, Lower Myanmar
First posted: 2010-09-10
Enrollment: 402
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Haemoglobin Level
timeFrame: at week 0, week 6 and week12
measure: Status of Tissue Iron Store
timeFrame: at week 0, week 6 and week12
measure: Status of Cellular Iron Deficiency
timeFrame: at week 0, week 6 and week12
Secondary outcomes:
Other outcomes:
Locations:
city: Pathein
country: Myanmar
facility: Nyaung Done Township
state: Irrawaddy Division
Study officials:
affiliation: (1) South East Asian Ministers of Education Organization, Regional Center for Food and Nutrition, University of Indonesia, (2) Ministry of Health, Myanmar
name: Min Kyaw Htet, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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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.
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.
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.