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| Name | Class |
|---|---|
| Food and Nutrition Research Institute, Philippines | OTHER_GOV |
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This study will follow a double blinded randomized controlled study design to enroll 20 apparently healthy 6 year old children. The children will be fed with two different nutrient fortified oat drinks labeled with stable isotopes of iron (Fe-57 or Fe-58 as NaFeEDTA). Fourteen days after consumption of meals on Day 2, blood will be drawn from the children for stable isotope measurements and iron absorption will be calculated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drink with Vit C then drink without Vit C | Experimental | Fortified oat drink with vitamin C on day 1 followed by fortified oat drink without vitamin C on day 2 |
|
| Drink without Vit C then drink with Vit C | Experimental | Fortified oat drink without vitamin C on day 1 followed by fortified oat drink with vitamin C on day 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary Intervention (with Vit C then without Vit C) | Other | Fortified oat drink with vitamin C followed by fortified oat drink without vitamin C |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Iron Absorption | Percentage of iron available for absorption from fortified oat drink with and without added vitamin C | 14 days after administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Trinidad P Trinidad, PhD | FNRI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Food and Nutrition Research Institute | City of Taguig | Philippines |
One subject was excluded prior to group assignment due to illness
Recruitment took place in August 2011
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| ID | Title | Description |
|---|---|---|
| FG000 | Drink With Vit C Then Drink Without Vit C | Dietary Intervention: Fortified oat drink with vitamin C followed by fortified oat drink without viatamin C |
| FG001 | Drink Without Vitamin C Then Drink With Vit C | Dietary Intervention: Fortified oat drink without vitamin C followed by fortified oat drink with vitamin C. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Drink With Vit C Then Drink Without Vit C | Dietary Intervention (with Vitamin C): Fortified oat drink with vitamin C followed by fortified oat drink without Vit C |
| BG001 | Drink Without Vit C Then Drink With Vit C |
| 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 | Percent Iron Absorption | Percentage of iron available for absorption from fortified oat drink with and without added vitamin C | Per protocol | Posted | Mean | Standard Error | percentage of Iron absorbed | 14 days after administration |
|
|
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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 | Drink With Vit C Then Drink Without Vit C | Dietary Intervention: Fortified oat drink with vitamin C followed by fortified oat drink without viatamin C |
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One of the isotopes was not detected in blood sample of 1 participant, therefore data from this participant was excluded from final per protocol analysis
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trinidad P. Trinidad | Food and Nutrition Research Institute | 6328372071 | 2281 | trinidadtp@yahoo.com.ph |
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| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D001205 | Ascorbic Acid |
| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
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| Dietary Intervention (without Vit C followed by with Vit C) | Other | Fortified oat drink without vitamin C followed by fortified oat drink with vitamin C |
|
Dietary Intervention (without Vitamin C): Fortified oat drink without vitamin C followed by fortified oat drink with vitamin C
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Customized | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Drink Without Vitamin C Then Drink With Vit C | Dietary Intervention: Fortified oat drink without vitamin C followed by fortified oat drink with vitamin C. | 0 | 0 | 0 | 0 |
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 18 months from the time submitted to the sponsor for review.
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |