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

NCT ID: NCT00799383

Last Updated: 2017-12-26

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2014-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Risperidone-induced Hyperprolactinemia

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Calcium and Vitamin D

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

Group Type EXPERIMENTAL

Calcium and Vitamin D

Intervention Type DRUG

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

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Interventions

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Calcium and Vitamin D

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

Intervention Type DRUG

Placebo

Intervention Type OTHER

Other Intervention Names

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Ca+VitD

Eligibility Criteria

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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

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., corticosteroids), 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 hypersensitivity to vitamin D products).
4. Laboratory values outside the normal range, except for prolactin, unless the deviations were not clinically significant (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.
Minimum Eligible Age

5 Years

Maximum Eligible Age

17 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Children's Miracle Network

OTHER

Sponsor Role collaborator

Chadi A. Calarge

OTHER

Sponsor Role lead

Responsible Party

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Chadi A. Calarge

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Chadi Calarge, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

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The University of Iowa

Iowa City, Iowa, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 29112461 (View on PubMed)

Other Identifiers

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K23MH085005

Identifier Type: NIH

Identifier Source: secondary_id

View Link

200807730

Identifier Type: -

Identifier Source: org_study_id