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| Name | Class |
|---|---|
| MannaRelief Ministries | UNKNOWN |
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This study will compare changes in body composition (lean mass, fat, and bone)and parent ratings of quality of life in 5-19 Year Olds as a function of participation in one of four versions of the Good NEWS 4 Kids Program (GN4K).
Purpose: The objectives of this study are to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MannaBears | Active Comparator | Subjects will take 4 MannaBears daily |
|
| MannaBears, AlgaeCal Calcium, Vitamin D3 | Active Comparator | Subjects will take 4 MannaBears daily and 3 Calcium/Vit D capsules (2 with breakfast and 1 with dinner or vice-versa) daily |
|
| MannaBears, Calcium Carbonate, Vitamin D3 | Active Comparator | Subjects will take 4 MannaBears daily and 3 Calcium/Vit D capsules (2 with breakfast and 1 with dinner or vice-versa) daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MannaBears | Dietary Supplement | Subjects will be administered 4 MannaBears daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in parental ratings of participating child's quality of life | Parent(s) will complete questionnaires on a monthly basis to assess the improvements made or improvements that have been made in various areas of their child's behavior and activities. Change from baseline to end of study will be reported. | 0 and 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in body composition as a measurement of Dual Energy Absorptiometry | Body composition (fat, fat-free mass, and bone mineral density) as measured by Dual Energy Absorptiometry (DXA) | 0 and 90 days |
| Changes in hip to waist ratios |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patricia L Keith, BBA | Contact | 210-824-4200 | hmrcenterstudy@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Gilbert R Kaats, PhD FACN | Integrative Health Technologies, Inc. | Principal Investigator |
| Harry G Preuss, MD MACN | Georgetown University Medical Center, Dept of Biochemistry, Medicine and Pathology | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Integrative Health Technologies | Recruiting | San Antonio | Texas | 78209 | United States |
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| AlgaeCal Calcium | Dietary Supplement | Subjects will be administered 750 mg AlgaeCal Calcium |
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| Calcium carbonate | Dietary Supplement | Subjects will be administered 1000 mg calcium carbonate |
|
| Vitamin D3 | Dietary Supplement | Subjects will be administered 800 IU vitamin D3 |
|
Parent(s) will be provided with a tape measure with which they will measure their child's hip and waist.
| 0 and 90 days |
| Changes in blood pressure | Blood pressure will be measured at the time the DXA measurement is completed. | 0 and 90 days |
| Changes in gender and age adjusted BMI | 0 and 90 days |
| ID | Term |
|---|---|
| D001835 | Body Weight |
| D044342 | Malnutrition |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D002119 | Calcium Carbonate |
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D017610 | Calcium Compounds |
| D007287 | Inorganic Chemicals |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
| D008903 | Minerals |
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
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