Clinical trial: Supplemental Calcium in Overweight People (NCT00030238)

Eligibility criteria:
-  INCLUSION CRITERIA: (Overweight Subjects)

        Volunteers will qualify if they meet the following criteria:

          1. Good general health. Individuals taking medication for obesity-related co-morbid
             conditions will not be excluded.

          2. Age greater than or equal to 18 years.

          3. Body Mass Index greater than or equal to 25 kg/m(2).

          4. For women with childbearing potential, a negative pregnancy test at the initial
             evaluation.

          5. Normal fasting serum Ca (2.05-2.55 mmol/L) and serum phosphorous levels (2.3 - 4.3
             mg/dl).

        INCLUSION CRITERIA: (Normal Weight Subjects)

        Volunteers will qualify if the meet the following criteria

          1. Good general health.

          2. Age greater than or equal to 18 years.

          3. Body Mass Index 1-24.99 kg/m(2)

          4. For women with childbearing potential, a negative pregnancy test at the initial
             evaluation. Since these subjects have to undergo DXA (dual Energy X-ray
             Absorptiometry) scan screening in their second visit, for safety purposes, pregnant
             women will be excluded from participation in the study.

          5. Normal fasting serum Ca (2.05-2.55 mmol/L) and serum phosphorus levels (2.3-4.3
             mg/dl).

             EXCLUSION CRITERIA: (overweight subjects)

             Volunteers will be excluded (and referred to non-experimental treatment programs as
             needed) for the following reasons:

               1. A presence of major illnesses: renal, hepatic (other than obesity-related
                  steatosis), gastrointestinal, most endocrinologic (e.g., Cushing syndrome, hyper-
                  or hypothyroidism), hematological problems or pulmonary disorders (other than
                  asthma not requiring continuous medication or sleep-apnea related disorders);

               2. Women who are pregnant, or who are currently nursing an infant; or who are having
                  unprotected intercourse;

               3. Individuals who have a current substance abuse or a psychiatric disorder or other
                  condition that in the opinion of the investigators would impede competence or
                  compliance or possibly hinder completion of the study;

               4. Subjects who regularly use prescription medications unrelated to the
                  complications of obesity {e.g., calcium channel blockers, diuretics (including
                  thiazide diuretics), beta-blockers etc}. Oral contraceptive use will be
                  permitted, provided the contraceptive has been used for at least two months
                  before starting study medication. The use of over-the-counter medications will be
                  reviewed on a case-by -case basis;

               5. Subjects who have a total calcium intake of more than 3.5 g/day on the screening
                  calcium intake questionnaire (SCQ) or more than 3 g/day of total calcium intake
                  on review of their 7-day food diaries;

               6. Subjects who take supplement calcium in excess of 300 mg/day or vitamin D
                  supplements in excess of 400 IU/day;

               7. Recent (3 months) use of anorexiant medications;

               8. History of renal stones;

               9. Intentional weight change of more than 3% of body weight in the past two months.

              10. Post-menopausal women who are medically advised to take calcium supplementation.

              11. Subjects with iPTH greater than 75 pg/ml (Normal range: 10-75 pg/ml) when
                  associated with a serum calcium level greater than 2.5 mmol/L. (normal range 2.05
                  to 2.55 mmol/L)

              12. Subjects with a serum 25-(OH)-D level less than 10 ng/ml (Normal range: 10-68
                  ng/ml) when associated with a serum 1-225-(OH)(2)-D level of less than 22 pg/ml
                  (Normal Range: 22-67 pg/ml.

              13. Subjects with a consistently (2 weeks apart) elevated systolic blood pressure of
                  greater than 160 mm Hg and/or a diastolic blood pressure greater than 95 mm Hg.

             EXCLUSION CRITERIA: (Normal Weight Subjects)

             Volunteers will be excluded (and referred to non-experimental treatment programs as
             needed) for the following reasons:

               1. Presence of major illnesses: renal (serum creatinine greater than 1.6), hepatic
                  (AST/ALT greater than 3 times upper limit of normal range used in Clinical Center
                  assays), gastrointestinal, most endocrinologic (e.g. Cushing syndrome, hyper- or
                  hyothyroidism), hematological problems or pulmonary disorders (other than asthma
                  not requiring continuous medication or sleep-apnea related disorders);

               2. Women who are pregnant, or who are currently nursing an infant;

               3. Individuals who have current substance abuse of a psychiatric disorder or other
                  condition that in the opinion of the investigators would impede competence or
                  compliance or possibly hinder completion of the study;

               4. Subjects who regularly use prescription medications. Oral contraceptive use will
                  be permitted, provided the contraceptive has been used for at least two months
                  before starting study medication. Individuals taking medications for most
                  conditions will be excluded, but medication use will be considered on a
                  case-by-case basis.

               5. Subjects who take supplemental calcium in excess of 300 mg/day or vitamin D
                  supplements in excess of 400 IU/day.

               6. Recent (3 months) use of anorexiant medications;

               7. Intentional weight change of more than 3% of body weight
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 9-year-old girl is brought to the office for evaluation of short stature and overweight body habitus. The patient's mother and father are 170 cm and 181 cm tall, respectively.  On physical examination, the patient's height is in the 5th percentile of her age.  Other findings include low-set ears, a high arched palate, a webbed neck, and cubitus valgus.  Chromosomal analysis reveals a 45, XO karyotype.

Patient description (patient's own words): I took my 9-year-old daughter to the doctor because my mother-in-law kept saying she seemed small and overweight. My husband and I are 170 cm and 181 cm tall, respectively. The physical health highlighted that she is in the 5th percentile of her age. The doctor said that she has low-set ears, a high-arched palate, a webbed neck, and cubitus valgus. She also did a chromosomal analysis, which revealed a 45, XO karyotype.

Does the patient match the trial criteria? Contradiction