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This intervention study will address the impact of vitamin D fortified milk and vitamin D supplements on the growth, levels of vitamin D, insulin-like growth factor 1, growth hormone, academic attention, respiratory infections, asthma, and flexural dermatitis (a proxy for eczema) of Mongolian children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Mongolian milk without D |
|
| 2 | Experimental | Mongolian milk with vitamin D |
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| 3 | Experimental | Ultra High Temperature (UHT) milk |
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| 4 | Experimental | Milk Substitute |
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| 5 | Experimental | Seasonal D |
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| 6 | Experimental | Daily D |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mongolian milk without vitamin D | Dietary Supplement | 710ml per day for 49 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum 25-hydroxyvitamin D Concentrations in Schoolchildren | Baseline and Follow-up 25(OH)D3 by liquid chromatography-tandem mass spectrometry | Blood was analyzed at day 0 and day 49 |
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Inclusion Criteria:
Children in 3rd and 4th grade from selected Mongolian schools.
School selection will consider:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janet Rich-Edwards, Sc.D. | Brigham and Women's Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17900364 | Background | Rich-Edwards JW, Ganmaa D, Pollak MN, Nakamoto EK, Kleinman K, Tserendolgor U, Willett WC, Frazier AL. Milk consumption and the prepubertal somatotropic axis. Nutr J. 2007 Sep 27;6:28. doi: 10.1186/1475-2891-6-28. | |
| 21697075 | Derived | Rich-Edwards JW, Ganmaa D, Kleinman K, Sumberzul N, Holick MF, Lkhagvasuren T, Dulguun B, Burke A, Frazier AL. Randomized trial of fortified milk and supplements to raise 25-hydroxyvitamin D concentrations in schoolchildren in Mongolia. Am J Clin Nutr. 2011 Aug;94(2):578-84. doi: 10.3945/ajcn.110.008771. Epub 2011 Jun 22. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Unfortified Mongolian Milk | Mongolian milk without vitamin D: 710ml per day for 49 days |
| FG001 | Fortified Mongolian Milk | Mongolian milk with vitamin D: 710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period. |
| FG002 | Fortified UHT Milk | UHT milk: 710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period. |
| FG003 | Daily Vitamin D Supplements | Daily D supplement: Deliver dosage of 13,700 IU vitamin D in vitamin capsules over 49 days. |
| FG004 | Seasonal Vitamin D Supplements | Seasonal D supplement: Deliver dosage of 13,700 IU vitamin D over 7 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Unfortified Mongolain Milk | Mongolian milk without vitamin D: 710ml per day for 49 days |
| BG001 | Fortified Mongolian Milk | Mongolian milk with vitamin D: 710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period. |
| 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 | Serum 25-hydroxyvitamin D Concentrations in Schoolchildren | Baseline and Follow-up 25(OH)D3 by liquid chromatography-tandem mass spectrometry | Posted | Mean | Standard Deviation | ng/ml | Blood was analyzed at day 0 and day 49 |
|
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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 | Unfortified Mongolain Milk | Mongolian milk without vitamin D: 710ml per day for 49 days |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Janet Rich-Edwards | Brigham and Women's Hospital | 617-525-7929 | jr33@partners.org |
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| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| D041941 | Milk Substitutes |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| Mongolian milk with vitamin D | Dietary Supplement | 710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period. |
|
|
| UHT milk | Dietary Supplement | 710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period. |
|
|
| Milk Substitute | Dietary Supplement | 710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period. |
|
|
| Seasonal D supplement | Dietary Supplement | Deliver dosage of 13,700 IU vitamin D over 7 days |
|
|
| Daily D supplement | Dietary Supplement | Deliver dosage of 13,700 IU vitamin D in vitamin capsules over 49 days. |
|
|
| Final blood draw not obtained |
|
| BG002 | Fortified UHT Milk | UHT milk: 710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period. |
| BG003 | Daily Vitamin D Supplements | Daily D supplement: Deliver dosage of 13,700 IU vitamin D in vitamin capsules over 49 days. |
| BG004 | Seasonal Vitamin D Supplements | Seasonal D supplement: Deliver dosage of 13,700 IU vitamin D over 7 days |
| BG005 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
UHT milk: 710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period. |
| OG003 | Daily Vitamin D Supplements | Daily D supplement: Deliver dosage of 13,700 IU vitamin D in vitamin capsules over 49 days. |
| OG004 | Seasonal Vitamin D Supplements | Seasonal D supplement: Deliver dosage of 13,700 IU vitamin D over 7 days |
|
|
| 0 |
| 101 |
| 0 |
| 101 |
| 0 |
| 101 |
| EG001 | Fortified Mongolian Milk | Mongolian milk with vitamin D: 710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period. | 0 | 140 | 0 | 140 | 0 | 140 |
| EG002 | Fortified UHT Milk | UHT milk: 710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period. | 0 | 137 | 0 | 137 | 0 | 137 |
| EG003 | Daily Vitamin D Supplements | Daily D supplement: Deliver dosage of 13,700 IU vitamin D in vitamin capsules over 49 days. | 0 | 109 | 0 | 109 | 0 | 109 |
| EG004 | Seasonal Vitamin D Supplements | Seasonal D supplement: Deliver dosage of 13,700 IU vitamin D over 7 days | 0 | 92 | 0 | 92 | 0 | 92 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001628 |
| Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |