NCT01855009

Brief Summary

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable quality-of-life

Timeline
Completed

Started May 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

May 8, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 16, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

June 24, 2013

Status Verified

June 1, 2013

Enrollment Period

7 months

First QC Date

May 8, 2013

Last Update Submit

June 21, 2013

Conditions

Quality of LifeBody Mass Index

Keywords

Quality of LifeBody Weight and MeasuresMalnutritionAdolescent Nutrition SciencesSleep Initiation and Maintenance DisorderMotor ActivityDrinking

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Changes in body composition as a measurement of Dual Energy Absorptiometry

    0 and 90 days

  • Changes in hip to waist ratios

    0 and 90 days

  • Changes in blood pressure

    0 and 90 days

  • Changes in gender and age adjusted BMI

    0 and 90 days

Study Arms (3)

MannaBears

ACTIVE COMPARATOR

Subjects will take 4 MannaBears daily

Dietary Supplement: MannaBears

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

Dietary Supplement: MannaBearsDietary Supplement: AlgaeCal CalciumDietary Supplement: Vitamin D3

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

Dietary Supplement: MannaBearsDietary Supplement: Calcium carbonateDietary Supplement: Vitamin D3

Interventions

MannaBearsDIETARY_SUPPLEMENT

Subjects will be administered 4 MannaBears daily

MannaBearsMannaBears, AlgaeCal Calcium, Vitamin D3MannaBears, Calcium Carbonate, Vitamin D3
AlgaeCal CalciumDIETARY_SUPPLEMENT

Subjects will be administered 750 mg AlgaeCal Calcium

MannaBears, AlgaeCal Calcium, Vitamin D3
Calcium carbonateDIETARY_SUPPLEMENT

Subjects will be administered 1000 mg calcium carbonate

MannaBears, Calcium Carbonate, Vitamin D3
Vitamin D3DIETARY_SUPPLEMENT

Subjects will be administered 800 IU vitamin D3

MannaBears, AlgaeCal Calcium, Vitamin D3MannaBears, Calcium Carbonate, Vitamin D3

Eligibility Criteria

Age5 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Must ensure with medical provider that there are not medical conditions that would preclude participation
  • Must be between the ages of 5 and 19

You may not qualify if:

  • males and females below the age of 5 and above the age of 19
  • pregnant or breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Integrative Health Technologies

San Antonio, Texas, 78209, United States

RECRUITING

MeSH Terms

Conditions

Body WeightMalnutritionMotor Activity

Interventions

Calcium CarbonateCholecalciferol

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsNutrition DisordersNutritional and Metabolic DiseasesBehavior

Intervention Hierarchy (Ancestors)

Calcium CompoundsInorganic ChemicalsCarbonatesCarbonic AcidCarbon Compounds, InorganicMineralsCholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • 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

Central Study Contacts

Patricia L Keith, BBA

CONTACT

210-824-4200hmrcenterstudy@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Gilbert R. Kaats, PhD

Study Record Dates

First Submitted

May 8, 2013

First Posted

May 16, 2013

Study Start

May 1, 2013

Primary Completion

December 1, 2013

Study Completion

March 1, 2014

Last Updated

June 24, 2013

Record last verified: 2013-06

Locations

US(1)