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

May 15, 2012 updated by: Min Kyaw Htet, Indonesia University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

402

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Myanmar
    • Irrawaddy Division
      • Pathein, Irrawaddy Division, Myanmar
        • Nyaung Done Township

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Iron group
Dietary supplement: Iron group
Ferrous fumarate, 60 mg, weekly dose
Other Names:
  • Iron supplement
Experimental: Vitamin A group
Dietary supplement: Vitamin A group
Retinol, weekly dose, 15,000 IU
Other Names:
  • Vitamin A supplement
Experimental: Iron and Vitamin A group
Dietary supplement: Iron and vitamin A group
Ferrous fumarate, Retinol combination group, weekly dose
Other Names:
  • Iron and Vitamin A supplement
Experimental: Placebo group
Placebo group with folic acid
Dietary supplement: Placebo group
folic acid only as placebo group
Other Names:
  • Placebo group, folic acid only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Haemoglobin Level
Time Frame: at week 0, week 6 and week12
Haemoglobin level (g/L) measured by cyanmethaemoglobin method
at week 0, week 6 and week12
Status of Tissue Iron Store
Time Frame: at week 0, week 6 and week12
Tissue iron store was measured by serum ferritin
at week 0, week 6 and week12
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
at week 0, week 6 and week12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Collaborators

Department of Medical Research, Lower Myanmar

Investigators

  • Principal Investigator: Min Kyaw Htet, PhD, (1) South East Asian Ministers of Education Organization, Regional Center for Food and Nutrition, University of Indonesia, (2) Ministry of Health, Myanmar

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

September 8, 2010

First Submitted That Met QC Criteria

September 9, 2010

First Posted (Estimate)

September 10, 2010

Study Record Updates

Last Update Posted (Estimate)

May 22, 2012

Last Update Submitted That Met QC Criteria

May 15, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCIVA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anemia

Clinical Trials on Iron group

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ukraine

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe