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

This study has been completed.
Sponsor:
Collaborators:
Children's Miracle Network
Information provided by (Responsible Party):
University of Iowa
ClinicalTrials.gov Identifier:
NCT00799383
First received: November 25, 2008
Last updated: April 2, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Risperidone-induced Hyperprolactinemia
Drug: Calcium and Vitamin D

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Counteracting Risperidone-Induced Hyperprolactinemia in Youths

Resource links provided by NLM:


Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • Trabecular bone mineral density in the ultradistal radius [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • total body bone mineral content [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Enrollment: 51
Study Start Date: November 2008
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Calcium+VitD Drug: 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.

Placebo Comparator: Placebo Drug: 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.


  Eligibility

Ages Eligible for Study:   5 Years to 17 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00799383

Locations
United States, Iowa
The University of Iowa
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
Children's Miracle Network
Investigators
Principal Investigator: Chadi Calarge, M.D. The University of Iowa
  More Information

No publications provided

Responsible Party: University of Iowa
ClinicalTrials.gov Identifier: NCT00799383     History of Changes
Other Study ID Numbers: K23-MH085005, K23MH085005
Study First Received: November 25, 2008
Last Updated: April 2, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Iowa:
Risperidone
hyperprolactinemia
children
adolescents
antipsychotics
prevention
calcium
vitamin D
Risperidone-induced hyperprolactinemia

Additional relevant MeSH terms:
Hyperprolactinemia
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Calcium, Dietary
Vitamin D
Ergocalciferols
Vitamins
Risperidone
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on August 28, 2014