CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 402 enrolled
Drug / intervention
Iron group +3 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01198574
NCT01198574Phase 3Completed

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

Indonesia University·interventional·Posted Sep 10, 2010·Updated May 22, 2012

In Brief

A Phase 3 clinical trial evaluating Iron group, Vitamin A group, and 2 other interventions for Anemia. Completed, enrolled 402 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnemia
CountriesBurma

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 10, 2010
Enrollment StartJul 1, 2010
Primary CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 15.8 years ago

Interventions

Iron groupdietary

Ferrous fumarate, 60 mg, weekly dose

Vitamin A groupdietary

Retinol, weekly dose, 15,000 IU

Iron and vitamin A groupdietary

Ferrous fumarate, Retinol combination group, weekly dose

Placebo groupdietary

folic acid only as placebo group