NCT03695328

Brief Summary

Peak bone mass acquisition through childhood and adolescence has been associated with lower risk of osteopenia and osteoporosis in the elderly. The main factors that influence bone mass are the non-modifiable, such as genetics, ethnicity and sex, and the modifiable ones which are nutrition and physical activity or exercise. In the literature are references that demonstrates positive effects of high physical activity, adequate intakes of macro- and micronutrients on bone mass both in adults and in children. Bone mineralization is more adaptive in childrens' growing bones and this is an opportunity for stronger effects by mechanical stimuli during physical activity. The presence of a diet complete of nutrient intakes seems to strengthen the effects of mechanical loads on bone growth and mineralization. The present trial aimed to evaluate the effects of physical activity and nutrition intakes on bone mass in pre-pubertal children.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
210

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2015

Typical duration for all trials

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2015

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 2, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 4, 2018

Completed
Last Updated

October 4, 2018

Status Verified

October 1, 2018

Enrollment Period

1 month

First QC Date

October 2, 2018

Last Update Submit

October 3, 2018

Conditions

Bone Status

Outcome Measures

Primary Outcomes (10)

  • Whole body bone mineral density

    Measured by Dual-X-ray Absoroptiometry

    1 day (Once)

  • Lumbar spine bone mineral density

    Measured by Dual-X-ray Absoroptiometry

    1 day (Once)

  • Hips bone mineral density

    Measured by Dual-X-ray Absoroptiometry

    1 day (Once)

  • Whole body mineral content

    Measured by Dual-X-ray Absoroptiometry

    1 day (Once)

  • Lumbar spine bone mineral content

    Measured by Dual-X-ray Absoroptiometry

    1 day (Once)

  • Hips bone mineral content

    Measured by Dual-X-ray Absoroptiometry

    1 day (Once)

  • Body composition

    Measured by Dual-X-ray Absoroptiometry and skinfolds

    1 day (Once)

  • Muscular strength

    Handgrip strength

    1 day (Once)

  • Cardiovascular endurance

    20m shuttle run test

    1 day (Once)

  • Flexibility

    Sit and reach test

    1 day (Once)

Secondary Outcomes (4)

  • Sclerostin

    1 day (Once)

  • Serum vitamin D

    1 day (Once)

  • Serum calcium

    1 day (Once)

  • Pubertal Stage

    1 day (Once)

Study Arms (2)

physical activity level

Children categorized either in the group with moderate to vigorous physical activity or in the group with low physical activity according the accelerometer's measures

Behavioral: physical activity level

dietary intake

Childrens' 24th dietary recalls for 7 days analyzed for protein, calcium, vitamin D and phosphorus intake and they categorized according the RDAs above or below them.

Behavioral: Dietary Intake

Interventions

physical activity levelBEHAVIORAL
physical activity level
Dietary IntakeBEHAVIORAL
dietary intake

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Primary schoolchildren (boys and girls) aged 6-12 years and were at pre-pubertal stage.

You may qualify if:

  • were 6-12 years and pre-pubertal
  • were healthy and had no prior bone fractures or related surgical operation
  • their body fat was \<30%, e) had no history of growth irregularities
  • were not receiving agents or drugs that affect bone tissue (e.g. Gonadotropin-Releasing Hormone (GnRH) agonists, antiresorptive, bisphosphonates, etc.)

You may not qualify if:

  • had prior bone fractures or related surgical operation
  • their body fat was \>30%
  • had history of growth irregularities
  • were receiving agents or drugs that affect bone tissue (e.g. GnRH agonists, antiresorptive, bisphosphonates, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Eating

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaDigestive System Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Officials

  • Theodoros Stampoulis, PhD student

    Democritus University of Thrace, Department of Physical Education & Sports Sciencies

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 2, 2018

First Posted

October 4, 2018

Study Start

September 15, 2015

Primary Completion

October 25, 2015

Study Completion

May 15, 2018

Last Updated

October 4, 2018

Record last verified: 2018-10