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This study is initiated to investigate the effect of multi micronutrient supplementation for 12 months on serum haemoglobin level in Indonesian young children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multi-micronutrients | Experimental | Multi-micronutrients |
|
| Maltodextrin and Lactose | Placebo Comparator | Placebo contained maltodextrin and lactose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multi-micronutrients | Dietary Supplement |
| ||
| Maltodextrin and Lactose |
| Measure | Description | Time Frame |
|---|---|---|
| Haemoglobin level | Change in serum haemoglobin level after 12 months of intervention | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Anemia prevalence | Change in anemia prevalence from baseline to after 12 months of intervention | 12 months |
| Anthropometric | Change in anthropometric measurements from baseline until 24 months of age |
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Inclusion Criteria:
Exclusion Criteria:
Haemoglobin < 8 g/dL at screening visit*.
Significant congenital abnormality which according to investigator's clinical judgement will interfere the study conduct and assessment
Any known conditions likely to affect nutrient absorption diagnosed by the child's physician
Disorders requiring a special diet (such as food intolerance or food allergy or complaints such as reflux, constipation and cramps for which special formula is required).
Any other current or previous illnesses/conditions or intervention which according to investigator's clinical judgement could interfere the study conduct and assessment (e.g. chronic illness or physical or mental handicaps)
Regular use of MMN supplements syrup (every day in > 1 week) within two weeks prior to entry into the study.
Not intending to use micronutrient supplements during the study
Participation in any other studies involving similar investigational or marketed products concomitantly or within two weeks prior to entry into the study.
Premature birth (gestational age <37 weeks)
Low birth weight (< 2500 g)
Severely under nutrition indicated by any of the following criteria: severely stunted: HAZ < -3 SD; severely underweight WAZ <-3 SD; wasted: WHZ <-2 SD
*Subject with haemoglobin level (finger prick blood sample) at screening visit between 8-10 g/dL will be given iron syrup supplementation for 1 month. Thereafter, haemoglobin level (whole blood sample) will be checked at baseline visit:
If Hb > 10 g/dL, subject is eligible for randomisation
If Hb < 10 g/dL, subject is not eligible for randomisation and will be given iron syrup supplementation for 2 months
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tonny Sundjaya, MD | Contact | tonny.sundjaya@danone.com |
| Name | Affiliation | Role |
|---|---|---|
| Rini Sekartini, MD, PhD | Medical Research Unit, Faculty of Medicine, University of Indonesia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jakarta | Indonesia |
|
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| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C008315 | maltodextrin |
| D007785 | Lactose |
| ID | Term |
|---|---|
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Dietary Supplement |
|
| 24 months of age |
| Micronutrients | Change in selected micronutrients status from baseline to after 12 months of intervention | 12 months |
| D000090463 |
| Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D000073893 |
| Sugars |