Sub-clinical Inflammation and Iron Supplementation

Study Overview
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Brief Summary
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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.

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

Conditions
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Anemia

Intervention / Treatment
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* Dietary Supplement: Iron group
* Dietary Supplement: Vitamin A group
* Dietary Supplement: Iron and vitamin A group
* Dietary Supplement: Placebo group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Iron group<br> | Dietary Supplement: Iron group<br>* Ferrous fumarate, 60 mg, weekly dose<br>* Other names: Iron supplement;|
| Experimental: Vitamin A group<br>Vitamin A group | Dietary Supplement: Vitamin A group<br>* Retinol, weekly dose, 15,000 IU<br>* Other names: Vitamin A supplement;|
| Experimental: Iron and Vitamin A group<br>Iron and Vitamin A group | Dietary Supplement: Iron and vitamin A group<br>* Ferrous fumarate, Retinol combination group, weekly dose<br>* Other names: Iron and Vitamin A supplement;|
| Experimental: Placebo group<br>Placebo group with folic acid | Dietary Supplement: Placebo group<br>* folic acid only as placebo group<br>* Other names: Placebo group, folic acid only;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Haemoglobin Level | Haemoglobin level (g/L) measured by cyanmethaemoglobin method | at week 0, week 6 and week12 | 
| Status of Tissue Iron Store | Tissue iron store was measured by serum ferritin | at week 0, week 6 and week12 | 
| Status of Cellular Iron Deficiency | Cellular Iron deficiency status is also measured by serum transferrin receptor | at week 0, week 6 and week12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anemia, iron supplementation, sub-clinical inflammation, adolescents