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Completed

NCT Number: NCT01198574

Sub-clinical Inflammation and Iron Supplementation

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.

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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

12 year–19 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Nyaung Done Township

Pathein, Ayeyarwady, Burma

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Iron group

Dietary Supplement

Ferrous fumarate, 60 mg, weekly dose

Other names: Iron supplement

Vitamin A group

Dietary Supplement

Retinol, weekly dose, 15,000 IU

Other names: Vitamin A supplement

Iron and vitamin A group

Dietary Supplement

Ferrous fumarate, Retinol combination group, weekly dose

Other names: Iron and Vitamin A supplement

Placebo Group

Dietary Supplement

folic acid only as placebo group

Other names: Placebo group, folic acid only

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Collaborators

  • Department of Medical Research, Lower Myanmar

Registry information

Official study title

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

Acronym: SCI&Anaemia

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Sep 10, 2010
Registry last updated
May 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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