Trial | NCT00000402  Report issue

Title

Calcium and Bone Mass in Young Females
Long Term Effects of Calcium on Bone Mass in Young Females

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    calcium ...

  • Study Participants

    354
We originally suggested that calcium in the diet is important in determining the amount of bone (bone mass) that builds up in young adults. We are testing the effect of calcium on bone mass in 354 Caucasian (white) girls. At the start of this 7-year study, the average age of the girls was 11 years, and they had not yet reached puberty. The study will also provide information about the effect of calcium on body composition (body fat) and blood pressure in young women.

We have been giving calcium to one group of participants in this study and giving a placebo (an inactive pill, or "sugar pill") to the other group. The results of this research will be important in preventing osteoporosis, because building more bone as a young person should reduce a woman's chances of developing osteoporosis later in life.
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.
Study Started
Aug 31
1991
Study Completion
Dec 31
2001
Last Update
May 22
2013
Estimate

Drug Calcium

Criteria 

Inclusion Criteria:

Pubertal stage II
Calcium intake below a threshold level
Caucasian
Normal health

Exclusion Criteria:

Medications affecting calcium and bone metabolism
Chronic diseases
Metabolic bone disease
Abnormality in calcium metabolism
No Results Posted