Phase 3
N=402
Sub-clinical Inflammation and Iron Supplementation
Anemia
Bottom Line
View on ClinicalTrials.gov: NCT01198574 ↗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
| Outcome | Result | p-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
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.