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Phase 3 N=402 Randomized Quadruple-blind Prevention

Sub-clinical Inflammation and Iron Supplementation

Anemia

Enrolled (actual)
402
Serious AEs
0.0%
Results posted
May 2012
Primary outcome: Primary: Haemoglobin Level — 88.3; 89.2; 88.4; 89.6 g/L — p=<0.05

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Iron group (Dietary_supplement); Vitamin A group (Dietary_supplement); Iron and vitamin A group (Dietary_supplement); Placebo group (Dietary_supplement)
Age
Pediatric, Adult · 12+ yrs
Sex
Female
Sponsor
Indonesia University
Primary completion
Dec 2010

Outcome Measures

OutcomeResultp-value
PRIMARY
Haemoglobin Level
88.3; 89.2; 88.4; 89.6; 98.1; 98.7 <0.05 sig
PRIMARY
Status of Tissue Iron Store
32.1; 34.4; 25.9; 31.1; 34.5; 32.1 <0.05 sig
PRIMARY
Status of Cellular Iron Deficiency
7.09; 6.56; 7.16; 6.74; 6.69; 6.39 <0.05 sig

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.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01198574). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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