MedTrace Logo

Sub-clinical Inflammation and Iron Supplementation

NCT01198574 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 402

Last updated 2012-05-22

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Iron group

Ferrous fumarate, 60 mg, weekly dose

DIETARY_SUPPLEMENT

Vitamin A group

Retinol, weekly dose, 15,000 IU

DIETARY_SUPPLEMENT

Iron and vitamin A group

Ferrous fumarate, Retinol combination group, weekly dose

DIETARY_SUPPLEMENT

Placebo group

folic acid only as placebo group

Sponsors & Collaborators

  • Department of Medical Research, Lower Myanmar

    collaborator OTHER

  • Indonesia University

    lead OTHER

Principal Investigators

  • 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

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
12 Years
Max Age
19 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • Burma

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01198574 on ClinicalTrials.gov