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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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
Are there results?: Yes, posted in the registrySummary in the doctors' view

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.

Burma1 site

Nyaung Done Township
Pathein, Ayeyarwady

Other trials in Burma

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 groups in NCT01198574
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.

Jul 2010Dec 2010

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)

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 20610634
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.
PubMed 18287375
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.
PubMed 18177514
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.
PubMed 16313694
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.
PubMed 7901629
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.
PubMed 9209187
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.
PubMed 10357747
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.
PubMed 24128336
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.
PubMed 22705432

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 22 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Role of Sub-clinical Inflammation on the Iron Status of Myanmar Anaemic Adolescent Schoolgirls During Iron and Vitamin A Supplementation
ClinicalTrials.gov ID: NCT01198574
Acronym / sponsor ID: SCI&Anaemia / SCIVA
Conditions: Anemia
Keywords: anemia, iron supplementation, sub-clinical inflammation, adolescents
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 402 participants (actual)
Lead sponsor: Universitas IndonesiaUniversity, hospital or other
Collaborators: Department of Medical Research, Lower Myanmar
Study start: Jul 2010
Primary completion: Dec 2010 (actual)
Study completion: Dec 2010 (actual)
First posted: 10 Sep 2010 (estimated)
Results: Posted 16 May 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Iron group	Experimental	Dietary Supplement: Iron group
Vitamin A group	Experimental	Dietary Supplement: Vitamin A groupVitamin A group
Iron and Vitamin A group	Experimental	Dietary Supplement: Iron and vitamin A groupIron and Vitamin A group
Placebo group	Experimental	Dietary Supplement: Placebo groupPlacebo group with folic acid

Who may qualify

Ages: 12 to 19 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (6 listed)

adolescent girls (age 12-19 years)
already experienced menarche
anemic girls (Hb<120 g/L)
no known illness (apparently healthy)
free from haemoglobinopathy

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Iron groupAlso: Iron supplementFerrous fumarate, 60 mg, weekly dose	Dietary supplement	Iron group
Vitamin A groupAlso: Vitamin A supplementRetinol, weekly dose, 15,000 IU	Dietary supplement	Vitamin A group
Iron and vitamin A groupAlso: Iron and Vitamin A supplementFerrous fumarate, Retinol combination group, weekly dose	Dietary supplement	Iron and Vitamin A group
Placebo groupAlso: Placebo group, folic acid onlyfolic acid only as placebo group	Dietary supplement	Placebo group

Primary outcome

Haemoglobin Level
Time frame: at week 0, week 6 and week12
Haemoglobin level (g/L) measured by cyanmethaemoglobin method
Status of Tissue Iron Store
Time frame: at week 0, week 6 and week12
Tissue iron store was measured by serum ferritin
Status of Cellular Iron Deficiency
Time frame: at week 0, week 6 and week12
Cellular Iron deficiency status is also measured by serum transferrin receptor

Results and safety

Results posted to the registry on 16 May 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Iron Group	98	94
Vitamin A Group	102	101
Iron and Vitamin A Group	100	99
Placebo Group	102	98

Primary outcome: Haemoglobin Level

Time frame: at week 0, week 6 and week12. Mean (Standard Deviation). Unit: g/L

Measure	Iron Group n = 94	Vitamin A Group n = 101	Iron and Vitamin A Group n = 98	Placebo Group n = 98
Hb week 0 (Baseline)	88.3 (11.2)	89.2 (11.5)	88.4 (12.1)	89.6 (12.7)
Hb week 6 (Midline)	98.1 (10.6)	98.7 (9.6)	99.2 (10.0)	98.3 (10.7)
Hb week 12 (Endline)	110.8 (9.8)	109.0 (9.1)	111.4 (9.0)	109.7 (8.4)

Iron Group vs Vitamin A Group vs Iron and Vitamin A Group vs Placebo Group: p <0.05, GLM for repeated measures

Population analysed: Per Protocol

Primary outcome: Status of Tissue Iron Store

Time frame: at week 0, week 6 and week12. Geometric mean (Standard Deviation). Unit: µg/L

Measure	Iron Group n = 94	Vitamin A Group n = 101	Iron and Vitamin A Group n = 98	Placebo Group n = 98
serum ferritin (Baseline)	32.1 (2.5)	34.4 (2.6)	25.9 (3.1)	31.1 (2.5)
serum ferritin (Midline)	34.5 (1.9)	32.1 (2.3)	32.3 (2.1)	26.5 (2.3)
serum ferritin (Endline)	39.6 (2.1)	35.0 (2.5)	35.4 (2.4)	28.2 (2.5)

Iron Group vs Vitamin A Group vs Iron and Vitamin A Group vs Placebo Group: p <0.05, GLM for repeated measures ANOVA

Population analysed: Per Protocol analysis

Primary outcome: Status of Cellular Iron Deficiency

Time frame: at week 0, week 6 and week12. Geometric mean (Standard Deviation). Unit: mg/L

Measure	Iron Group n = 94	Vitamin A Group n = 101	Iron and Vitamin A Group n = 98	Placebo Group n = 98
serum transferrin receptor (Baseline)	7.09 (1.52)	6.56 (1.42)	7.16 (1.59)	6.74 (1.50)
serum transferrin receptor (Midline)	6.69 (1.51)	6.39 (1.41)	6.73 (1.53)	6.59 (1.53)
serum transferrin receptor (Endline)	6.44 (1.55)	6.27 (1.44)	6.24 (1.43)	6.61 (1.54)

Iron Group vs Vitamin A Group vs Iron and Vitamin A Group vs Placebo Group: p <0.05, GLM for repeated measures ANOVA

Population analysed: Per Protocol analysis

Adverse events

Time frame: The adverse effect of supplementation were collected weekly throughout the 12 weeks of intervention.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Iron Group	0 of 98 (0%)	0 of 98 (0%)	Not reported
Vitamin A Group	0 of 102 (0%)	0 of 102 (0%)	Not reported
Iron and Vitamin A Group	0 of 100 (0%)	0 of 100 (0%)	Not reported
Placebo Group	0 of 102 (0%)	0 of 102 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 20610634Thurnham 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.
Background: PubMed 18287375Mburu 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.
Background: PubMed 18177514Thurnham 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.
Background: PubMed 16313694Thurnham 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.
Background: PubMed 7901629Thurnham 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.
Background: PubMed 9209187Angeles-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.
Background: PubMed 10357747Tee 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.
Derived from this study: PubMed 24128336Htet 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.
Derived from this study: PubMed 22705432Htet 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.
South East Asian Ministers of Education Organization, Regional Center for Food and Nutrition, University of IndonesiaLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 May 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Burma. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 May 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Haemoglobin Level (time frame: at week 0, week 6 and week12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01198574, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2012.