AnemiaPhase 3SCI&AnaemiaNCT01198574
Sub-clinical Inflammation and Iron Supplementation
A Phase 3 study testing Iron group, Vitamin A group and Iron and vitamin A group in people with Anemia, run by Universitas Indonesia at 1 site in Burma.
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… Read more about this study
- Who is it for?
- Ages 12 to 19 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anemia
- What is being tested?
- Iron group, Vitamin A group and Iron and vitamin A group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 402 participants
- Where
- 1 siteBurma
- Study dates
- Jul 2010to Dec 2010
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 19 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- subjects with chronic illness
- subjects with severe anaemia
- who do not give the consents
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Sub-clinical Inflammation on the Iron Status of Myanmar Anaemic Adolescent Schoolgirls During Iron and Vitamin A Supplementation
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
- Being tested
- Iron group, Vitamin A group, Iron and vitamin A group, Placebo group
- Keywords
- anemia, iron supplementation, sub-clinical inflammation, adolescents
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron groupDietary supplement
Also called Iron supplement
Ferrous fumarate, 60 mg, weekly dose
Vitamin A groupDietary supplement
Also called Vitamin A supplement
Retinol, weekly dose, 15,000 IU
Iron and vitamin A groupDietary supplement
Also called Iron and Vitamin A supplement
Ferrous fumarate, Retinol combination group, weekly dose
Placebo groupDietary supplement
Also called Placebo group, folic acid only
folic acid only as placebo group
| Study group | Role | What they receive |
|---|---|---|
| Iron group | Experimental | Not described Receives: Dietary Supplement: Iron group |
| Vitamin A group | Experimental | Vitamin A group Receives: Dietary Supplement: Vitamin A group |
| Iron and Vitamin A group | Experimental | Iron and Vitamin A group Receives: Dietary Supplement: Iron and vitamin A group |
| Placebo group | Experimental | Placebo group with folic acid Receives: Dietary Supplement: Placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Haemoglobin Level
Haemoglobin level (g/L) measured by cyanmethaemoglobin method
Measured: at week 0, week 6 and week12
Status of Tissue Iron Store
Tissue iron store was measured by serum ferritin
Measured: at week 0, week 6 and week12
Status of Cellular Iron Deficiency
Cellular Iron deficiency status is also measured by serum transferrin receptor
Measured: at week 0, week 6 and week12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2010 (estimated)
- Study startJul 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 402 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Medical Research, Lower Myanmar
- Responsible party
- Principal investigator, Min Kyaw Htet, Universitas Indonesia
- Investigators
- Min Kyaw Htet, PhD, Principal investigator, (1) South East Asian Ministers of Education Organization, Regional Center for Food and Nutrition, University of Indonesia, (2) Ministry of Health, Myanmar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01198574
- Sponsor's protocol ID
- SCIVA
- Acronym
- SCI&Anaemia
- Status last verified
- May 2012
- First submitted
- 8 Sep 2010
- Last updated
- 22 May 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 20610634Mburu 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.
PubMed 18287375Thurnham 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.
PubMed 18177514Thurnham 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.
PubMed 16313694Thurnham 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.
PubMed 7901629Angeles-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.
PubMed 9209187Tee 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.
PubMed 10357747Htet 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.
PubMed 24128336Htet 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.
PubMed 22705432