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| ID | Type | Description | Link |
|---|---|---|---|
| 230831 | Other Grant/Funding Number | CIHR |
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| Name | Class |
|---|---|
| Mead Johnson Nutrition | INDUSTRY |
The immune system of newborn infants is immature with low activity of both innate and acquired immune reactions. Early nutrition has an impact on early immune responses. Dietary fatty acids are one nutritional factor noted to play a role in immune function. The omega-6 long-chain polyunsaturated fatty acid, ARA (Arachidonic acid) and the omega-3 fatty acid, DHA (docosahexaenoic acid) are found naturally in breastmilk and some infant formulas. The balance or relative amounts of ARA and DHA have been associated with immune response. Some commercial infant formula contains both ARA and DHA. However, the optimal balance of ARA and DHA has not been determined with respect to immune function. This study will assess two levels of ARA and the impact on immune response in healthy, term infants and whether genes that influence essential fatty acid metabolism alter the nutritional requirement of infants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 34 mg/100 kcal arachidonic acid | Active Comparator | 10 weeks exclusive feeding with infant formula containing 34 mg/100 kcal of arachidonic acid |
|
| 25 mg/100 kcal arachidonic acid | Active Comparator | 10 weeks exclusive feeding with infant formula containing 25 mg/100 kcal of arachidonic acid |
|
| Infant formula without arachidonic acid | Placebo Comparator | 10 weeks exclusive infant formula feeding (without supplemental arachidonic acid). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arachidonic acid (25 mg/100 kcal ) | Dietary Supplement |
| ||
| Arachidonic acid (34 mg/100 kcal) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Antigen-presenting B Cells | 10 weeks |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael T Clandinin, PhD | University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alberta Hospital | Edmonton | Alberta | T6G 2B7 | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | 34 mg/100 kcal Arachidonic Acid | 10 weeks exclusive feeding with infant formula containing 34 mg/100 kcal of arachidonic acid |
| FG001 | 25 mg/100 kcal Arachidonic Acid | 10 weeks exclusive feeding with infant formula containing 25 mg/100 kcal of arachidonic acid |
| FG002 | Infant Formula Without Arachidonic Acid | 10 weeks exclusive infant formula feeding (without supplemental arachidonic acid). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 34 mg/100 kcal Arachidonic Acid | 10 weeks exclusive feeding with infant formula containing 34 mg/100 kcal of arachidonic acid |
| BG001 | 25 mg/100 kcal Arachidonic Acid | 10 weeks exclusive feeding with infant formula containing 25 mg/100 kcal of arachidonic acid |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Antigen-presenting B Cells | Posted | Number | percentage of CD20+ B cells | 10 weeks |
|
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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 | 34 mg/100 kcal Arachidonic Acid | 10 weeks exclusive feeding with infant formula containing 34 mg/100 kcal of arachidonic acid |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| sudden unexpected infant death | General disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| swallowing disorder | Ear and labyrinth disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Tom Clandinin | University of Alberta | 7804925188 | tclandin@ualberta.ca |
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| ID | Term |
|---|---|
| D016718 | Arachidonic Acid |
| ID | Term |
|---|---|
| D001095 | Arachidonic Acids |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
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| Dietary Supplement |
|
| Placebo | Dietary Supplement | 10 weeks exclusive infant formula feeding (without supplemental arachidonic acid). |
|
| BG002 | Infant Formula Without Arachidonic Acid | 10 weeks exclusive infant formula feeding (without supplemental arachidonic acid). |
| BG003 | Total | Total of all reporting groups |
| days |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 1 |
| 30 |
| 2 |
| 30 |
| EG001 | 25 mg/100 kcal Arachidonic Acid | 10 weeks exclusive feeding with infant formula containing 25 mg/100 kcal of arachidonic acid | 0 | 30 | 7 | 30 |
| EG002 | Infant Formula Without Arachidonic Acid | 10 weeks exclusive infant formula feeding (without supplemental arachidonic acid). | 0 | 29 | 3 | 29 |
| gastroesophageal reflux | Gastrointestinal disorders |
|
| constipation | Gastrointestinal disorders |
|
| colic | Gastrointestinal disorders |
|
| diarrhea | Gastrointestinal disorders |
|
| cow's milk intolerance | Gastrointestinal disorders |
|
| eczema | Skin and subcutaneous tissue disorders |
|
| rash | Skin and subcutaneous tissue disorders |
|
| inguinal hernia - male | Renal and urinary disorders |
|
| other | Renal and urinary disorders |
|
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| D008055 |
| Lipids |
| D005228 | Fatty Acids, Essential |