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Status unknownNCT03284294Updated Apr 2, 2020

Influence of Vitamin D Supplementation on Serum BDNF Level and Cognitive Function in Schizophrenia

A Phase 3 interventional study of Cholecalciferol and Placebo in Schizophrenia, sponsored by Universitas Padjadjaran. Status unknown. Open to male participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2020-04-02.

Sponsored by Universitas Padjadjaran · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Male
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Study summary

The objective of the study is to evaluate the influence of vitamin D supplementation on Serum Brain Derived Neurotrophic Factor level and cognitive function in schizophrenia treated with atypical antipsychotic. Methods: The investigator will use randomized controlled trial design. 40 chronic schizophrenia patients with vitamin D insufficiency or deficiency treated with atypical antipsychotic, will be randomly assign (1:1 ratio) to receive either daily oral cholecalciferol 2000 IU or placebo for 8 weeks. Assessment of BDNF serum and cognitive function will be performed at baseline and after 8 weeks period.

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Conditions studied

  • Schizophrenia

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Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • Chronic schizophrenia
  • Serum 25(OH)D level below 30 ng/ml
  • Deficit in cognitive functions

Exclusion criteria

Exclusion Criteria:

  • Hypercalcemia
  • Hepatic or renal failure
  • Obese
  • Metabolic syndrome
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Placebo comparator
    Placebo

    Oral placebo daily for 8 weeks

    Drug: Placebo

  • Active comparator
    Vitamin D

    Vitamin D Cholecalciferol 2000 IU oral daily for 8 weeks

    Drug: Cholecalciferol

Interventions

  • DrugCholecalciferol

    cholecalciferol 2000 IU oral daily for 8 weeks

  • DrugPlacebo

    Oral placebo daily for 8 weeks

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What researchers measure

Primary outcomes

  1. Cognitive Function

    cognitive function as measured with standard cognitive battery

    Time frame: At the end of week 8

Secondary outcomes

  1. BDNF serum level

    BDNF serum level as measured with ELISA method

    Time frame: At the end of week 8

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT03284294
Lead sponsor
Universitas Padjadjaran
Responsible party
Tuti Kurnianingsih (Principal Investigator, Universitas Padjadjaran) — Principal investigator
First posted
Sep 15, 2017
Start date
Apr 15, 2020 (estimated)
Primary completion
Aug 2020 (estimated)
Completion
Dec 2020 (estimated)
Last update
Apr 2, 2020

Study contacts

Tuti Kurnianingsih, MD
Contact
kurniatuti@gmail.com
+62 812 232 9249

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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