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Study of the Effect of a Calcium-rich Diet on Bone Health in Girls (Calkids)

C

Creighton University

Status and phase

Completed
Phase 3

Conditions

Bone Health

Treatments

Other: Calcium rich diet
Other: calcium-rich diet

Study type

Interventional

Funder types

Other

Identifiers

NCT01058109
97-11179

Details and patient eligibility

About

The aim of this experimental study was to test the effect of increasing dietary calcium intake to 1500 mg/day on increases in bone quality in adolescent females. The hypothesis to be tested is: adolescent females who consume a high calcium diet will have a greater increase in bone quality, as measured by densitometry and ultrasound, than adolescent females who consume their usual dietary calcium intake.

Enrollment

65 patients

Sex

Female

Ages

9 to 9 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Inclusion criteria were being female and nine years of age with usual dietary calcium intake 1100 mg/day or less.

Exclusion criteria

  • Exclusion criteria included history of any of the following: lactose intolerance, milk allergy, corticosteroid or anticonvulsant therapy, familial hypercholesterolemia, mental or physical handicaps, cancer, rheumatoid arthritis, asthma, or any significant health problem reported by the parents. We also excluded any child who had a body mass index (BMI)85th percentile for age and gender and children who practiced or played any organized sport (including gymnastics or dance) more than three times per week.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

65 participants in 2 patient groups

calcium group
Experimental group
Description:
dietary calcium intake of 1500 mg/d
Treatment:
Other: calcium-rich diet
calcium-rich diet (1500 mg/d)
Experimental group
Description:
calcium intake from food
Treatment:
Other: Calcium rich diet

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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