Sub-clinical Inflammation and Iron Supplementation

Phase 3

Completed

• Conditions: Anemia
• Interventions: Dietary Supplement: Iron group; Dietary Supplement: Vitamin A group; Dietary Supplement: Iron and vitamin A group; Dietary Supplement: Placebo group

• Registration Number: NCT01198574
• Lead Sponsor: Indonesia University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-09-08
• Study First Submitted QC: 2010-09-09
• Study First Posted: 2010-09-10
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Results First Submitted: 2011-12-31
• Results First Submitted QC: 2012-04-17
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-15
• Results First Posted: 2012-05-16
• Last Update Posted: 2012-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 402

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Iron group	Iron group	-
Vitamin A group	Vitamin A group	Vitamin A group
Iron and Vitamin A group	Iron and vitamin A group	Iron and Vitamin A group
Placebo group	Placebo group	Placebo group with folic acid

Primary Outcome Measures

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

Trial Locations

Locations (1)

Nyaung Done Township; 🇲🇲 Pathein, Irrawaddy Division, Myanmar