Recruiting

Observational Study

Sponsor:

Integrative Health Technologies, Inc.

Code:

NCT01855009

Conditions

Quality of Life

Body Mass Index

Eligibility Criteria

Sex: All

Age: 5 - 19

Healthy Volunteers: Accepted

Interventions

MannaBears

AlgaeCal Calcium

Calcium carbonate

Vitamin D3

Study Details

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).

Conditions

Quality of Life

Body Mass Index

Study ID

NCT01855009

Start date

May, 2013

Status verified date

Jun, 2013

Completion date

Mar, 2014

Anticipated

Primary completion date

Dec, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 19

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Interventions and Outcome Measures

Arms

active comparator: MannaBears

Subjects will take 4 MannaBears daily

active comparator: MannaBears, AlgaeCal Calcium, Vitamin D3

Subjects will take 4 MannaBears daily and 3 Calcium/Vit D capsules (2 with breakfast and 1 with dinner or vice-versa) daily

active comparator: MannaBears, Calcium Carbonate, Vitamin D3

Subjects will take 4 MannaBears daily and 3 Calcium/Vit D capsules (2 with breakfast and 1 with dinner or vice-versa) daily

Interventions

MannaBears

Subjects will be administered 4 MannaBears daily

AlgaeCal Calcium

Subjects will be administered 750 mg AlgaeCal Calcium

Calcium carbonate

Subjects will be administered 1000 mg calcium carbonate

Vitamin D3

Subjects will be administered 800 IU vitamin D3

Primary outcome measure

  • Change from baseline in parental ratings of participating child's quality of life [ Time Frame: 0 and 90 days ]

Central Contacts and Locations

Central contacts

Patricia L Keith, BBA

210-824-4200hmrcenterstudy@gmail.com

Locations

Integrative Health Technologies

Recruiting

San Antonio, Texas, United States, 78209

More Information

Sponsor

Integrative Health Technologies, Inc.

Last update posted

Jun 24, 2013

Last verified

Jun, 2013

Keywords

  • Quality of Life
  • Body Weight and Measures
  • Malnutrition
  • Adolescent Nutrition Sciences
  • Sleep Initiation and Maintenance Disorder
  • Motor Activity
  • Drinking

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Integrative Health Technologies, Inc. on 2013-06-24.