Sub-clinical Inflammation and Iron Supplementation

Anemia Clinical Trial

— SCI&Anaemia  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01198574
• Other study ID #: SCIVA
• Status: Completed
• Phase: Phase 3
• First received: September 8, 2010
• Last updated: May 15, 2012
• Start date: July 2010
• Est. completion date: December 2010

Study information

• Verified date: May 2012
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Myanmar:Department of Medical Research, Lower Myanmar.
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 402
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 12 Years to 19 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anemia
• Inflammation

Intervention

Dietary Supplement:
• Iron group
Ferrous fumarate, 60 mg, weekly dose
• Vitamin A group
Retinol, weekly dose, 15,000 IU
• Iron and vitamin A group
Ferrous fumarate, Retinol combination group, weekly dose
• Placebo group
folic acid only as placebo group

Locations

Country	Name	City	State
Myanmar	Nyaung Done Township	Pathein	Irrawaddy Division

Sponsors (2)

Lead Sponsor	Collaborator
Indonesia University	Department of Medical Research, Lower Myanmar

Country where clinical trial is conducted

Myanmar, 

References & Publications (7)

Angeles-Agdeppa I, Schultink W, Sastroamidjojo S, Gross R, Karyadi D. Weekly micronutrient supplementation to build iron stores in female Indonesian adolescents. Am J Clin Nutr. 1997 Jul;66(1):177-83. — View Citation

Mburu AS, Thurnham DI, Mwaniki DL, Muniu EM, Alumasa F, de Wagt A. The influence and benefits of controlling for inflammation on plasma ferritin and hemoglobin responses following a multi-micronutrient supplement in apparently healthy, HIV+ Kenyan adults. J Nutr. 2008 Mar;138(3):613-9. — View Citation

Tee ES, Kandiah M, Awin N, Chong SM, Satgunasingam N, Kamarudin L, Milani S, Dugdale AE, Viteri FE. School-administered weekly iron-folate supplements improve hemoglobin and ferritin concentrations in Malaysian adolescent girls. Am J Clin Nutr. 1999 Jun;69(6):1249-56. — View Citation

Thurnham DI, Mburu AS, Mwaniki DL, De Wagt A. Micronutrients in childhood and the influence of subclinical inflammation. Proc Nutr Soc. 2005 Nov;64(4):502-9. Review. — View Citation

Thurnham DI, Mburu AS, Mwaniki DL, Muniu EM, Alumasa F, de Wagt A. Using plasma acute-phase protein concentrations to interpret nutritional biomarkers in apparently healthy HIV-1-seropositive Kenyan adults. Br J Nutr. 2008 Jul;100(1):174-82. doi: 10.1017/S0007114507883012. Epub 2008 Jan 4. — View Citation

Thurnham DI, McCabe LD, Haldar S, Wieringa FT, Northrop-Clewes CA, McCabe GP. Adjusting plasma ferritin concentrations to remove the effects of subclinical inflammation in the assessment of iron deficiency: a meta-analysis. Am J Clin Nutr. 2010 Sep;92(3):546-55. doi: 10.3945/ajcn.2010.29284. Epub 2010 Jul 7. — View Citation

Thurnham DI. Vitamin A, iron, and haemopoiesis. Lancet. 1993 Nov 27;342(8883):1312-3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Haemoglobin Level	Haemoglobin level (g/L) measured by cyanmethaemoglobin method	at week 0, week 6 and week12	No
Primary	Status of Tissue Iron Store	Tissue iron store was measured by serum ferritin	at week 0, week 6 and week12	No
Primary	Status of Cellular Iron Deficiency	Cellular Iron deficiency status is also measured by serum transferrin receptor	at week 0, week 6 and week12	No

External Links

•   South East Asian Ministers of Education Organization, Regional Center for Food and Nutrition, University of Indonesia