Completed

Treatment of Calcium Deficiency in Young Women

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What is being tested

Calcium supplement

Drug
Who is being recruted

Bone Diseases+3

+ Bone Diseases, Metabolic

+ Metabolic Diseases

From 19 to 27 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: January 1995
See protocol details

Summary

Principal SponsorCreighton University
Last updated: June 28, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 1995

Actual date on which the first participant was enrolled.

This is a randomized, controlled trial of calcium carbonate supplementation (1500 milligrams per day) in third-decade women with low calcium-to-protein intakes. We accept women aged 19-27 on the basis of good health and the 7-day food diary demonstrating a dietary calcium-to-protein ratio (in milligrams:grams) that does not exceed 13. The outcome variable is the change in BMD at hip, total body, forearm, and spine. Treatment lasts for 3 years. We expect that bone mass will increase in both groups but will increase to a greater extent in the calcium-supplemented group than in the nonsupplemented group.

NCT00000426
Principal SponsorCreighton University
Last updated: June 28, 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

150 patients to be enrolled

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

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


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 19 to 27 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

2 inclusion criteria required to participate
Dietary calcium-to-protein ratio (in mg:g, as assessed by 7-day food diary) does not exceed 13

Women in good health

4 exclusion criteria prevent from participating
Endocrine disease

Lactation

Pregnancy

Smoking

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

Creighton University

Omaha, United StatesOpen Creighton University in Google Maps
CompletedOne Study Center