ClinicalTrials.gg
Sign In
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verified this record recently (last verified Mar 2020), so the status shown — last known as Not yet recruiting — may be out of date.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
01

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.

02

Conditions studied

  • Schizophrenia

Browse trials for

03

In context

Schizophrenia

3,565 studies on the registry are indexed under Schizophrenia; 491 are open to participants now.

This study's planned enrollment of 40 is below the median of 71 across 2,944 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Universitas Padjadjaran is the lead sponsor of 93 studies on the registry; 23 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 45 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

  • 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
05

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

06

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Apr 2020; primary completion for Aug 2020, 4 months later.

Of 113 phase 3 interventional studies under Schizophrenia, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 46. This study's planned 4 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 4, 2017
First posted
Sep 15, 2017
StartEst.
Apr 15, 2020
Primary completionEst.
Aug 2020
CompletionEst.
Dec 2020
Last update
Apr 2, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 2, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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.

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 drug tested here: Cholecalciferol

Other studies in this condition

Schizophrenia →

Other studies from this sponsor

Universitas Padjadjaran

Start the discussion