Sub-clinical Inflammation and Iron Supplementation

NCT01198574 | Completed Phase 3 Results

• 1 other identifier: SCIVA
• Study Type: interventional
• Target: 402
• Locations: 1 country
• Sites: 1

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.

Conditions

Anemia

Keywords

anemia; iron supplementation; sub-clinical inflammation; adolescents

Outcome Measures

Primary Outcomes (3)

• Haemoglobin Level

  Haemoglobin level (g/L) measured by cyanmethaemoglobin method

  at week 0, week 6 and week12

• Status of Tissue Iron Store

  Tissue iron store was measured by serum ferritin

  at week 0, week 6 and week12

• Status of Cellular Iron Deficiency

  Cellular Iron deficiency status is also measured by serum transferrin receptor

  at week 0, week 6 and week12

Study Arms (4)

Iron group

EXPERIMENTAL

Dietary Supplement: Iron group

Vitamin A group

EXPERIMENTAL

Vitamin A group

Dietary Supplement: Vitamin A group

Iron and Vitamin A group

EXPERIMENTAL

Iron and Vitamin A group

Dietary Supplement: Iron and vitamin A group

Placebo group

EXPERIMENTAL

Placebo group with folic acid

Dietary Supplement: Placebo group

Interventions

Iron group DIETARY_SUPPLEMENT

Ferrous fumarate, 60 mg, weekly dose

Also known as: Iron supplement

Iron group

Vitamin A group DIETARY_SUPPLEMENT

Retinol, weekly dose, 15,000 IU

Also known as: Vitamin A supplement

Vitamin A group

Iron and vitamin A group DIETARY_SUPPLEMENT

Ferrous fumarate, Retinol combination group, weekly dose

Also known as: Iron and Vitamin A supplement

Iron and Vitamin A group

Placebo group DIETARY_SUPPLEMENT

folic acid only as placebo group

Also known as: Placebo group, folic acid only

Placebo group

Eligibility Criteria

• Age: 12 Years - 19 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• subjects with chronic illness
• subjects with severe anaemia
• who do not give the consents

Sponsors & Collaborators

• Indonesia University: lead
• Department of Medical Research, Lower Myanmar: collaborator

Study Sites (1)

Nyaung Done Township

Pathein, Ayeyarwady Region, Burma

Location

Related Publications (9)

• 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.

  PMID: 20610634 BACKGROUND

• 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. doi: 10.1093/jn/138.3.613.

  PMID: 18287375 BACKGROUND

• 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.

  PMID: 18177514 BACKGROUND

• 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. doi: 10.1079/pns2005468.

  PMID: 16313694 BACKGROUND

• Thurnham DI. Vitamin A, iron, and haemopoiesis. Lancet. 1993 Nov 27;342(8883):1312-3. doi: 10.1016/0140-6736(93)92239-p. No abstract available.

  PMID: 7901629 BACKGROUND

• 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. doi: 10.1093/ajcn/66.1.177.

  PMID: 9209187 BACKGROUND

• 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. doi: 10.1093/ajcn/69.6.1249.

  PMID: 10357747 BACKGROUND

• Htet MK, Fahmida U, Dillon D, Akib A, Utomo B, Thurnham DI. The influence of vitamin A status on iron-deficiency anaemia in anaemic adolescent schoolgirls in Myanmar. Public Health Nutr. 2014 Oct;17(10):2325-32. doi: 10.1017/S1368980013002723. Epub 2013 Oct 16.

  PMID: 24128336 DERIVED

• Htet MK, Dillon D, Akib A, Utomo B, Fahmida U, Thurnham DI. Microcytic anaemia predominates in adolescent school girls in the delta region of Myanmar. Asia Pac J Clin Nutr. 2012;21(3):411-5.

  PMID: 22705432 DERIVED

Related Links

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

MeSH Terms

Conditions

Anemia

Interventions

Iron-Dextran Complex; Iron

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Dextrans; Glucans; Polysaccharides; Carbohydrates; Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Results Point of Contact

• Title: Dr. Min Kyaw Htet, Township Health Officer, Ministry of Health, Myanmar
• Organization: South East Asia Ministers of Education Organization, Regional Center for Food and Nutrition

kyawhtet@gmail.com

+62-857-27262672

Study Officials

• Min Kyaw Htet, PhD

  (1) South East Asian Ministers of Education Organization, Regional Center for Food and Nutrition, University of Indonesia, (2) Ministry of Health, Myanmar

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: September 8, 2010
• First Posted: September 10, 2010
• Study Start: July 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: May 22, 2012
• Results First Posted: May 16, 2012

Record last verified: 2012-05

Locations

BU (1)