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| Name | Class |
|---|---|
| Department of Medical Research, Lower Myanmar | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iron group | Experimental |
| |
| Vitamin A group | Experimental | Vitamin A group |
|
| Iron and Vitamin A group | Experimental | Iron and Vitamin A group |
|
| Placebo group | Experimental | Placebo group with folic acid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iron group | Dietary Supplement | Ferrous fumarate, 60 mg, weekly dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nyaung Done Township | Pathein | Ayeyarwady | Burma |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20610634 | Background | 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. | |
| 18287375 | Background |
| Label | URL |
|---|---|
| South East Asian Ministers of Education Organization, Regional Center for Food and Nutrition, University of Indonesia | View source |
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Deworming with 400 mg Albendazole was done one week before the baseline data collection.
Screening for the study subjects was conducted in July, 2010 among the adolescent schoolgirls in Nyaung Done Township, Irrawaddy Division. It included assessment of Hb status using the Coulter Counter. Information on the general characteristics and menarche status of the girls are obtained.
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| ID | Title | Description |
|---|---|---|
| FG000 | Iron Group | Iron group received 60 mg of elemental iron, 2.5 mg folic acid + Placebo Vitamin A weekly |
| FG001 | Vitamin A Group | Vitamin A group received 15,000 IU Vitamin A + Placebo iron containing 2.5 mg folic acid weekly |
| FG002 | Iron and Vitamin A Group | Iron and Vitamin A group received 60 mg elemental iron, 2.5 mg folic acid + 15,000 IU Vitamin A weekly |
| FG003 | Placebo Group | Placebo group received 2.5 mg folic acid weekly |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Iron Group | Iron group received 60 mg elemental iron, 2.5 mg folic acid with vitamin A placebo weekly |
| BG001 | Vitamin A Group | Vitamin A group received 15,000 IU Vitamin A + Iron placebo with 2.5 mg folic acid weekly |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Haemoglobin Level | Haemoglobin level (g/L) measured by cyanmethaemoglobin method | Per Protocol | Posted | Mean | Standard Deviation | g/L | at week 0, week 6 and week12 |
|
The adverse effect of supplementation were collected weekly throughout the 12 weeks of intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Iron Group | Iron group received 60 mg elemental iron, 2.5 mg folic acid with vitamin A placebo weekly |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Min Kyaw Htet, Township Health Officer, Ministry of Health, Myanmar | South East Asia Ministers of Education Organization, Regional Center for Food and Nutrition | +62-857-27262672 | kyawhtet@gmail.com |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D007505 | Iron-Dextran Complex |
| D007501 | Iron |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003911 | Dextrans |
| D005936 | Glucans |
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| Vitamin A group | Dietary Supplement | Retinol, weekly dose, 15,000 IU |
|
|
| Iron and vitamin A group | Dietary Supplement | Ferrous fumarate, Retinol combination group, weekly dose |
|
|
| Placebo group | Dietary Supplement | folic acid only as placebo group |
|
|
| 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. |
| 18177514 | 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. |
| 16313694 | 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. |
| 7901629 | 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. |
| 9209187 | 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. |
| 10357747 | 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. |
| 24128336 | Derived | 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. |
| 22705432 | 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. |
| BG002 | Iron and Vitamin A Group | Iron and Vitamin A group received 60 mg elemental iron, 2.5 mg folic acid +15,000 IU Vitamin A weekly |
| BG003 | Placebo Group | Placebo group received iron placebo containing 2.5 mg folic acid weekly |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
60 mg Elemental iron with 2.5 mg folic acid + Vitamin A 15,000 IU
| OG003 | Placebo Group | 2.5 mg folic acid + Vitamin A placebo |
|
|
|
| Primary | Status of Tissue Iron Store | Tissue iron store was measured by serum ferritin | Per Protocol analysis | Posted | Geometric Mean | Standard Deviation | µg/L | at week 0, week 6 and week12 |
|
|
|
|
| Primary | Status of Cellular Iron Deficiency | Cellular Iron deficiency status is also measured by serum transferrin receptor | Per Protocol analysis | Posted | Geometric Mean | Standard Deviation | mg/L | at week 0, week 6 and week12 |
|
|
|
|
| 0 |
| 98 |
| 0 |
| 98 |
| EG001 | Vitamin A Group | Vitamin A group received 15,000 IU Vitamin A + Iron placebo with 2.5 mg folic acid weekly | 0 | 102 | 0 | 102 |
| EG002 | Iron and Vitamin A Group | Iron and Vitamin A group received 60 mg elemental iron, 2.5 mg folic acid +15,000 IU Vitamin A weekly | 0 | 100 | 0 | 100 |
| EG003 | Placebo Group | Placebo group received iron placebo containing 2.5 mg folic acid weekly | 0 | 102 | 0 | 102 |
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| D011134 |
| Polysaccharides |
| D002241 | Carbohydrates |
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
| D008670 | Metals |
| serum ferritin (Midline) |
|
| serum ferritin (Endline) |
|
| serum transferrin receptor (Midline) |
|
| serum transferrin receptor (Endline) |
|