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| ID | Type | Description | Link |
|---|---|---|---|
| K23MH085005 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
| Children's Miracle Network | OTHER |
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The purpose of this study is to determine whether calcium and vitamin D supplementation, over a nine-month period, optimizes bone mineralization in boys with risperidone-induced hyperprolactinemia. We hypothesize that, by the end of the stuy, children in the supplementation group will have higher bone mineral density compared to those in the placebo group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Calcium and Vitamin D | Experimental | Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period. |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcium and Vitamin D | Drug | Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Trabecular Bone Mineral Density in the Ultradistal Radius | Peripheral quantitative computed tomography (pQCT) scan was obtained at the 4% and 20% sites of the nondominant radius to estimate trabecular and cortical BMD, respectively. A Stratec XCT-2000 scanner, software version 6.0 (Stratec, Inc., Pforzheim, Germany),was used. Trabecular BMD was measured as the mean density of the 85% central area of the bone's cross-section. Outcomes were measured at baseline, 18 weeks, and 36 weeks later. | 36 weeks |
| Total Body Bone Mineral Content | Outcomes were measured at baseline, 18 weeks, and 36 weeks later. | 36 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Bone Strength Index, mg2/mm4 | Measured at the 4% radius site. | 36 weeks |
| Cortical Bone Mineral Density | This was measured at the 20% radius site. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chadi Calarge, M.D. | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Iowa | Iowa City | Iowa | 52242 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29112461 | Derived | Calarge CA, Mills JA, Ziegler EE, Schlechte JA. Calcium and Vitamin D Supplementation in Boys with Risperidone-Induced Hyperprolactinemia: A Randomized, Placebo-Controlled Pilot Study. J Child Adolesc Psychopharmacol. 2018 Mar;28(2):145-150. doi: 10.1089/cap.2017.0104. Epub 2017 Nov 7. |
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Participants were required to have been in treatment with risperidone for at least one year.
They should have had a prolactin concentration ≥ 18.4 ng/ml on two occasions, within one week.
Between 02/2009 and 11/2013, medically-healthy 5 to 17 year-old risperidone-treated boys were enrolled, via screening of the electronic medical records, referrals, and word of mouth.
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| ID | Title | Description |
|---|---|---|
| FG000 | Calcium+VitD | Calcium and Vitamin D: Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period. |
| FG001 | Placebo | Placebo administered in similarly looking capsules. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Calcium+VitD | Calcium and Vitamin D: Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period. I labelled the intervention type as "drug", even though "dietary supplement" would be more appropriate as the system sent the following error message: ERROR: An IND/IDE study must have at least one intervention of type: Drug, Device, Biological/Vaccine, Radiation or Genetic. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Trabecular Bone Mineral Density in the Ultradistal Radius | Peripheral quantitative computed tomography (pQCT) scan was obtained at the 4% and 20% sites of the nondominant radius to estimate trabecular and cortical BMD, respectively. A Stratec XCT-2000 scanner, software version 6.0 (Stratec, Inc., Pforzheim, Germany),was used. Trabecular BMD was measured as the mean density of the 85% central area of the bone's cross-section. Outcomes were measured at baseline, 18 weeks, and 36 weeks later. | The number at baseline is smaller than the randomized number because bone scans with movement artifact were discarded. At late time points, the sample size reflects both attrition and exclusion due to movement artifact. | Posted | Mean | Standard Deviation | mg/cm^3 | 36 weeks |
|
Data collected during 36 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Calcium+VitD | Calcium and Vitamin D: Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period. I labelled the intervention type as "drug", even though "dietary supplement" would be more appropriate as the system sent the following error message: ERROR: An IND/IDE study must have at least one intervention of type: Drug, Device, Biological/Vaccine, Radiation or Genetic. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stomach ache | Gastrointestinal disorders | Systematic Assessment |
Failure to enroll vitamin D deficient patients. The supplements dose were modest. The sample size was small. We may have included too broad a pubertal stage. We did not supplement other micronutrients. We did not include females.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chadi Calarge, MD | Baylor College of Medicine | 832-824-4764 | chadi.calarge@bcm.edu |
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| ID | Term |
|---|---|
| D006966 | Hyperprolactinemia |
| ID | Term |
|---|---|
| D006964 | Hyperpituitarism |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
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| ID | Term |
|---|---|
| D002118 | Calcium |
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
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| Placebo | Other |
|
| 36 weeks |
| Cortical Thickness | This was measured at the 20% radius site. | 36 weeks |
| Periosteal Circumference | This was measured at the 20% radius site. | 36 weeks |
| Endosteal Circumference | This was measured at the 20% radius site. | 36 weeks |
| Polar Section Modulus | This was measured at the 20% radius site. | 36 weeks |
| Lost to Follow-up |
|
| Urinary Calcium/Creatinine > 0.2 |
|
| Withdrawal by Subject |
|
| BG001 | Placebo | Calcium and Vitamin D: Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period. I labelled the intervention type as "drug", even though "dietary supplement" would be more appropriate as the system sent the following error message: ERROR: An IND/IDE study must have at least one intervention of type: Drug, Device, Biological/Vaccine, Radiation or Genetic. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Total Body Less Head Bone Mineral Content Z-score | This measure is based on a whole-body dual energy x-ray absorptiometry (DXA) scan. | Mean | Standard Deviation | Z-score |
|
| Trabecular Bone Mineral Density, mg/cm3 | The number at baseline is smaller than the randomized number because bone scans with movement artifact were discarded | Mean | Standard Deviation | mg/cm3 |
|
| OG001 | Placebo | Calcium and Vitamin D: Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period. I labelled the intervention type as "drug", even though "dietary supplement" would be more appropriate as the system sent the following error message: ERROR: An IND/IDE study must have at least one intervention of type: Drug, Device, Biological/Vaccine, Radiation or Genetic. |
|
|
| Primary | Total Body Bone Mineral Content | Outcomes were measured at baseline, 18 weeks, and 36 weeks later. | Numbers below reflect attrition. | Posted | Mean | Standard Deviation | Z score (age-sex-height-race specific) | 36 weeks |
|
|
|
| Secondary | Bone Strength Index, mg2/mm4 | Measured at the 4% radius site. | Sample size is smaller because scans with movement artifact were removed at baseline. At follow up, attrition also contributed. | Posted | Mean | Standard Deviation | mg^2/mm^4 | 36 weeks |
|
|
|
| Secondary | Cortical Bone Mineral Density | This was measured at the 20% radius site. | Sample size reduced due to exclusion of scans with movement artifact and, in later visits, due to attrition as well. | Posted | Mean | Standard Deviation | mg/cm^3 | 36 weeks |
|
|
|
| Secondary | Cortical Thickness | This was measured at the 20% radius site. | Sample size reduced due to exclusion of scans with movement artifact and, in later visits, due to attrition as well. | Posted | Mean | Standard Deviation | mm | 36 weeks |
|
|
|
| Secondary | Periosteal Circumference | This was measured at the 20% radius site. | Sample size reduced due to exclusion of scans with movement artifact and, in later visits, due to attrition as well. | Posted | Mean | Standard Deviation | mm | 36 weeks |
|
|
|
| Secondary | Endosteal Circumference | This was measured at the 20% radius site. | Sample size reduced due to exclusion of scans with movement artifact and, in later visits, due to attrition as well. | Posted | Mean | Standard Deviation | mm | 36 weeks |
|
|
|
| Secondary | Polar Section Modulus | This was measured at the 20% radius site. | Sample size reduced due to exclusion of scans with movement artifact and, in later visits, due to attrition as well. | Posted | Mean | Standard Deviation | mm^3 | 36 weeks |
|
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| 11 |
| 23 |
| EG001 | Placebo | Calcium and Vitamin D: Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period. I labelled the intervention type as "drug", even though "dietary supplement" would be more appropriate as the system sent the following error message: ERROR: An IND/IDE study must have at least one intervention of type: Drug, Device, Biological/Vaccine, Radiation or Genetic. | 0 | 24 | 0 | 24 | 8 | 24 |
| Bloating | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea/Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Urinary calcium/Creatinine Ratio | Renal and urinary disorders | Systematic Assessment |
|
| Increased energy | Psychiatric disorders | Systematic Assessment |
|
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| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
| D001779 |
| Blood Coagulation Factors |
| D001685 | Biological Factors |
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
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| At 18 Weeks |
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| At 36 Weeks |
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