A Phase 3 interventional study of Iron group and Vitamin A group in Anemia, sponsored by Indonesia University. Completed at 1 site in Myanmar. Open to female participants aged 12 Years to 19 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-05-22.
Sponsored by Indonesia University · Phase 3, Interventional, and Prevention
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.
1,810 studies on the registry are indexed under Anemia; 215 are open to participants now.
This study's enrollment of 402 is above the median of 117 across 1,336 interventional studies indexed under Anemia.
Browse Anemia studies →Indonesia University is the lead sponsor of 446 studies on the registry; 56 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dietary Supplement: Iron group
Vitamin A group
Dietary Supplement: Vitamin A group
Iron and Vitamin A group
Dietary Supplement: Iron and vitamin A group
Placebo group with folic acid
Dietary Supplement: Placebo group
Ferrous fumarate, 60 mg, weekly dose
Also known as: Iron supplement
Retinol, weekly dose, 15,000 IU
Also known as: Vitamin A supplement
Ferrous fumarate, Retinol combination group, weekly dose
Also known as: Iron and Vitamin A supplement
folic acid only as placebo group
Also known as: Placebo group, folic acid only
Haemoglobin Level
Haemoglobin level (g/L) measured by cyanmethaemoglobin method
Time frame: at week 0, week 6 and week12
Status of Tissue Iron Store
Tissue iron store was measured by serum ferritin
Time frame: at week 0, week 6 and week12
Status of Cellular Iron Deficiency
Cellular Iron deficiency status is also measured by serum transferrin receptor
Time frame: at week 0, week 6 and week12
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.
| Milestone | Iron Group | Vitamin A Group | Iron and Vitamin A Group | Placebo Group |
|---|---|---|---|---|
| Started | 98 | 102 | 100 | 102 |
| Completed | 94 | 101 | 99 | 98 |
| Not completed | 4 | 1 | 1 | 4 |
| Withdrew: Resigned from schools | 4 | 1 | 1 | 4 |
Haemoglobin level (g/L) measured by cyanmethaemoglobin method
| g/L | Iron Group | Vitamin A Group | Iron and Vitamin A Group | Placebo Group |
|---|---|---|---|---|
| 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 |
Tissue iron store was measured by serum ferritin
| µg/L | Iron Group | Vitamin A Group | Iron and Vitamin A Group | Placebo Group |
|---|---|---|---|---|
| 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 |
Cellular Iron deficiency status is also measured by serum transferrin receptor
| mg/L | Iron Group | Vitamin A Group | Iron and Vitamin A Group | Placebo Group |
|---|---|---|---|---|
| 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 |
Collected over The adverse effect of supplementation were collected weekly throughout the 12 weeks of intervention.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Iron Group | — | 0/98 (0%) | 0/98 (0%) |
| Vitamin A Group | — | 0/102 (0%) | 0/102 (0%) |
| Iron and Vitamin A Group | — | 0/100 (0%) | 0/100 (0%) |
| Placebo Group | — | 0/102 (0%) | 0/102 (0%) |
| Age, Categorical(Participants) | Iron Group | Vitamin A Group | Iron and Vitamin A Group | Placebo Group | Total |
|---|---|---|---|---|---|
| <=18 years | 98 | 102 | 100 | 102 | 402 |
| Between 18 and 65 years | 0 | 0 | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 | 0 | 0 |
| Age Continuous(years) | Iron Group | Vitamin A Group | Iron and Vitamin A Group | Placebo Group | Total |
|---|---|---|---|---|---|
| Mean | 15.9 ± 1.2 | 16.1 ± 1.2 | 16.1 ± 1.2 | 15.8 ± 1.1 | 16.0 ± 1.2 |
| Sex: Female, Male(Participants) | Iron Group | Vitamin A Group | Iron and Vitamin A Group | Placebo Group | Total |
|---|---|---|---|---|---|
| Female | 98 | 102 | 100 | 102 | 402 |
| Male | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Iron Group | Vitamin A Group | Iron and Vitamin A Group | Placebo Group | Total |
|---|---|---|---|---|---|
| Myanmar | 98 | 102 | 100 | 102 | 402 |
This study is completed, as verified in May 2012. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Iron · Vitamin A