Calcium and Vitamin D to Optimize Bone Mass in Boys With Risperidone-induced Hyperprolactinemia
Condition: Risperidone-induced Hyperprolactinemia
MeSH terms: Hyperprolactinemia
Intervention: Calcium and Vitamin D; Placebo
Intervention description: Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period.
Intervention MeSH terms: Vitamin D; Calcium
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 47.0
Sex: Male
Minimum age: 5 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Risperidone; hyperprolactinemia; children; adolescents; antipsychotics; prevention; calcium; vitamin D; Risperidone-induced hyperprolactinemia

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.
    

Eligibility 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.