Completed

Long Term Effects of Calcium on Bone Mass in Young Females

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What is being tested

Calcium

Drug
Who is being recruted

Bone Diseases+3

+ Bone Diseases, Metabolic

+ Metabolic Diseases

From 8 to 13 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Phase 2
Interventional
Study Start: August 1991
See protocol details

Summary

Principal SponsorOhio State University
Last updated: May 22, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 1991

Actual date on which the first participant was enrolled.

This study evaluates the effect of calcium on bone mass accretion over 7 years in a cohort of 354 young females who were in pubertal Stage II at the start of the study. The average age of study participants at entry was 11 years; at the end of the study participants were 18 years old. The study looks at skeletal development under the influence of heredity, nutrition (calcium), and physical exercise. We gave calcium to participants in one arm of this clinical trial calcium. Participants in the other arm of the trial were given a placebo. The main outcome variable is the bone mass measured at different skeletal regions. The study will also provide data about the efficacy of calcium supplementation with regard to hypertension prevention and obesity. The results of this research will be important in preventing osteoporosis.

NCT00000402
Principal SponsorOhio State University
Last updated: May 22, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

354 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 8 to 13 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bone DiseasesBone Diseases, MetabolicMetabolic DiseasesMusculoskeletal DiseasesNutritional and Metabolic DiseasesOsteoporosis

Criteria

4 inclusion criteria required to participate
Calcium intake below a threshold level
Caucasian
Normal health
Pubertal stage II
4 exclusion criteria prevent from participating
Abnormality in calcium metabolism
Chronic diseases
Medications affecting calcium and bone metabolism
Metabolic bone disease

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

OSU Bone and Mineral Metabolism Laboratory

Columbus, United StatesOpen OSU Bone and Mineral Metabolism Laboratory in Google Maps
CompletedOne Study Center