ClinicalTrials.gg
Sign In
CompletedNCT00799383Updated Dec 26, 2017Results posted

Calcium and Vitamin D to Optimize Bone Mass in Boys With Risperidone-induced Hyperprolactinemia

A Phase 3 interventional study of Calcium and Vitamin D and Placebo in Risperidone-induced Hyperprolactinemia, sponsored by Chadi A. Calarge. Completed at 1 site in United States. Open to male participants aged 5 Years to 17 Years. Per ClinicalTrials.gov, last updated 2017-12-26.

Sponsored by Chadi A. Calarge · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
47
Allocation
Randomized
Ages
5 Years to 17 Years
Sex
Male
01

Study summary

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.

02

Conditions studied

  • Risperidone-induced Hyperprolactinemia

Browse trials for

Keywords

  • Risperidone
  • hyperprolactinemia
  • children
  • adolescents
  • antipsychotics
  • prevention
  • calcium
  • vitamin D
  • Risperidone-induced hyperprolactinemia
03

In context

Hyperprolactinemia

39 studies on the registry are indexed under Hyperprolactinemia; 4 are open to participants now.

This study's enrollment of 47 is below the median of 60 across 20 interventional studies indexed under Hyperprolactinemia.

Browse Hyperprolactinemia studies →

Lead sponsor

Chadi A. Calarge is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 17 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Males (age range: 5-17yo; inclusive), in treatment with risperidone for ≥ one year.
  2. The participants must have two measurements of prolactin ≥ 18.4 ng/ml, obtained within a week.
  3. IQ > 35-40 (≥ Moderate intellectual disability).
  4. An adult parent/guardian must be available to provide consent and dispense study medication.

Exclusion criteria

Exclusion Criteria:

  1. Chronic disorders involving a vital organ (heart, lung, liver, kidney, brain), metabolic diseases (e.g., diabetes, hypo- or hyperparathyroidism, hypo- or hyperthyroidism, growth hormone deficiency), other skeletal diseases (e.g., Paget's disease, osteogenesis imperfecta, rheumatoid arthritis), chronic use of drugs affecting bone metabolism (e.g., ), and malnutrition conditions (e.g., chronic diarrhea, inflammatory bowel disease), congenital disorders, or lead poisoning.
  2. Participants receiving calcium or multivitamins in the previous three months.
  3. A history of renal calculi and fasting random urine calcium/creatinine ratio > 0.2 or any other medical disorder that contraindicates the use of calcium or vitamin D (e.g., hypercalcemic states, hypercoagulability disorders, vitamin D toxicity, malabsorption syndrome, or to vitamin D products).
  4. Laboratory values outside the normal range, except for prolactin, unless the deviations were not (e.g. TSH \< 10 μIU/ml (76)).
  5. Inability to cooperate with the BMD measurements.
  6. Bilateral wrist or forearm fractures.
  7. Eating disorders.
  8. Non-compliance with the prescribed psychiatric treatment as reflected by an undetectable combined risperidone and 9-hydroxy risperidone blood concentration.
  9. Plans to move out of State within the next 9 months.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
47 participants (actual)

Study arms

  • Experimental
    Calcium and Vitamin D

    Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period.

    Drug: Calcium and Vitamin D

  • Placebo comparator
    Placebo

    Placebo

    Other: Placebo

Interventions

  • DrugCalcium and Vitamin D

    Drug pages: Calcium · Vitamin D

    Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period.

    Also known as: Ca+VitD

  • OtherPlacebo
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 36 weeks

  2. Total Body Bone Mineral Content

    Outcomes were measured at baseline, 18 weeks, and 36 weeks later.

    Time frame: 36 weeks

Secondary outcomes

  1. Bone Strength Index, mg2/mm4

    Measured at the 4% radius site.

    Time frame: 36 weeks

  2. Cortical Bone Mineral Density

    This was measured at the 20% radius site.

    Time frame: 36 weeks

  3. Cortical Thickness

    This was measured at the 20% radius site.

    Time frame: 36 weeks

  4. Periosteal Circumference

    This was measured at the 20% radius site.

    Time frame: 36 weeks

  5. Endosteal Circumference

    This was measured at the 20% radius site.

    Time frame: 36 weeks

  6. Polar Section Modulus

    This was measured at the 20% radius site.

    Time frame: 36 weeks

07

Results

Posted Dec 26, 2017
Limitations and caveats
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.

Participant flow

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.

Participant flow — Overall Study
MilestoneCalcium+VitDPlacebo
Started2324
Completed2018
Not completed36
Withdrew: Protocol violation11
Withdrew: Adverse event01
Withdrew: Lost to follow-up12
Withdrew: Urinary calcium/creatinine > 0.211
Withdrew: Withdrawal by subject01

Outcome measures

PrimaryTrabecular 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.

Time frame:
36 weeks
Reported as:
Mean · mg/cm^3
Trabecular Bone Mineral Density in the Ultradistal Radius
mg/cm^3Calcium+VitDPlacebo
Baseline192.9 ± 31.1197.2 ± 43.9
At 18 Weeks191.0 ± 38.4194.6 ± 41.2
At 36 Weeks195.7 ± 36.9213.1 ± 42.1
PrimaryTotal Body Bone Mineral Content

Outcomes were measured at baseline, 18 weeks, and 36 weeks later.

Time frame:
36 weeks
Reported as:
Mean · Z score (age-sex-height-race specific)
Total Body Bone Mineral Content
Z score (age-sex-height-race specific)Calcium+VitDPlacebo
At Baseline0.10 ± 0.790.12 ± 0.68
At 18 Weeks0.24 ± 0.810.23 ± 0.76
At 36 Weeks0.20 ± 0.860.17 ± 0.78
SecondaryBone Strength Index, mg2/mm4

Measured at the 4% radius site.

Time frame:
36 weeks
Reported as:
Mean · mg^2/mm^4
Bone Strength Index, mg2/mm4
mg^2/mm^4Calcium+VitDPlacebo
Baseline19.8 ± 8.125.3 ± 15.9
week 1821.0 ± 9.122.9 ± 14.3
week 3623.1 ± 9.626.1 ± 14.5
SecondaryCortical Bone Mineral Density

This was measured at the 20% radius site.

Time frame:
36 weeks
Reported as:
Mean · mg/cm^3
Cortical Bone Mineral Density
mg/cm^3Calcium+VitDPlacebo
Baseline1059.6 ± 34.81063.2 ± 30.6
week 181062.8 ± 34.51060.2 ± 27.1
week 361069.3 ± 31.81058.7 ± 27.4
SecondaryCortical Thickness

This was measured at the 20% radius site.

Time frame:
36 weeks
Reported as:
Mean · mm
Cortical Thickness
mmCalcium+VitDPlacebo
Baseline2.25 ± 0.322.34 ± 0.50
week 182.25 ± 0.342.26 ± 0.45
week 362.32 ± 0.352.34 ± 0.44
SecondaryPeriosteal Circumference

This was measured at the 20% radius site.

Time frame:
36 weeks
Reported as:
Mean · mm
Periosteal Circumference
mmCalcium+VitDPlacebo
Baseline30.1 ± 4.332.4 ± 5.4
week 1831.2 ± 4.332.6 ± 6.1
week 3631.4 ± 4.032.3 ± 5.1
SecondaryEndosteal Circumference

This was measured at the 20% radius site.

Time frame:
36 weeks
Reported as:
Mean · mm
Endosteal Circumference
mmCalcium+VitDPlacebo
Baseline16.0 ± 3.417.7 ± 3.6
week 1817.0 ± 3.918.4 ± 5.1
week 3616.8 ± 3.717.6 ± 4.0
SecondaryPolar Section Modulus

This was measured at the 20% radius site.

Time frame:
36 weeks
Reported as:
Mean · mm^3
Polar Section Modulus
mm^3Calcium+VitDPlacebo
Baseline123.8 ± 53.6156.2 ± 76.6
week 18134.5 ± 55.1156.8 ± 91.9
week 36137.2 ± 49.2151.9 ± 75.6

Adverse events

Collected over Data collected during 36 weeks.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Calcium+VitD0/23 (0%)0/23 (0%)11/23 (47.8%)
Placebo0/24 (0%)0/24 (0%)8/24 (33.3%)
Most frequent other events
Most frequent other events
EventCalcium+VitDPlacebo
Stomach acheGastrointestinal disorders5/233/24
ConstipationGastrointestinal disorders5/233/24
Nausea/VomitingGastrointestinal disorders4/230/24
DiarrheaGastrointestinal disorders2/231/24
BloatingGastrointestinal disorders1/230/24
Urinary calcium/Creatinine RatioRenal and urinary disorders1/231/24
Increased energyPsychiatric disorders0/231/24

Baseline characteristics

Age, Continuous
Age, Continuous(years)Calcium+VitDPlaceboTotal
Mean10.8 ± 3.012.1 ± 3.011.5 ± 3.0
Sex: Female, Male
Sex: Female, Male(Participants)Calcium+VitDPlaceboTotal
Female000
Male232447
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Calcium+VitDPlaceboTotal
Hispanic or Latino202
Not Hispanic or Latino212445
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Calcium+VitDPlaceboTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American156
White211940
More than one race000
Unknown or Not Reported101
Total Body Less Head Bone Mineral Content Z-score
Total Body Less Head Bone Mineral Content Z-score(Z-score)Calcium+VitDPlaceboTotal
Mean0.10 ± 0.790.12 ± 0.680.11 ± 0.73
Trabecular Bone Mineral Density, mg/cm3
Trabecular Bone Mineral Density, mg/cm3(mg/cm3)Calcium+VitDPlaceboTotal
Mean192.9 ± 31.1197.2 ± 43.9195.0 ± 37.5
08

Study locations

1 site
  • The University of Iowa
    Iowa City, Iowa 52242, United States
09

References and documents

Publications

  • 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. PubMed 29112461 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 26, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00799383
Lead sponsor
Chadi A. Calarge
Collaborators
National Institute of Mental Health (NIMH), Children's Miracle Network
Responsible party
Chadi A. Calarge (Principal Investigator, University of Iowa) — Sponsor-investigator
First posted
Nov 27, 2008
Start date
Nov 2008
Primary completion
Mar 2014
Completion
Mar 2014
Results posted
Dec 26, 2017
Last update
Dec 26, 2017

Study contacts

Chadi Calarge, M.D.
principal investigator · University of Iowa

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drugs tested here: Calcium · Vitamin D

Other studies in this condition

Hyperprolactinemia →

Other studies from this sponsor

Chadi A. Calarge

Start the discussion