N/A N=33 Randomized Double-blind Treatment

Vitamin D Supplementation for Bipolar Depression

Bipolar Disorder · Bipolar Depression

Bottom Line

View on ClinicalTrials.gov: NCT01884844 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2018

Primary outcome: Primary: Change in Montgomery-Åsberg Depression Rating Scale — 9.4; 6.4 units on a scale — p=0.89

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Vitamin D3, Cholecalciferol (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Massachusetts, Worcester
Primary completion: Aug 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Montgomery-Åsberg Depression Rating Scale	9.4; 6.4	0.89

Summary

The purpose of this study is to whether vitamin d supplementation in those with low levels may reduce depression symptoms in people experiencing bipolar depression.

Eligibility Criteria

Inclusion Criteria

Adults >18years old
Bipolar disorder (I,II or NOS),
MADRS Score>7 (mild),
25(OH)D level <30ng/ml (insufficient).
able to take the prescribed vitamin D by mouth

Exclusion Criteria

Systemic diseases such as:

liver and kidney diseases,
known parathyroid disorder,
disorders of vitamin D metabolism,
taking vitamin D replacement therapy,
fat digestion disorder,
diabetes mellitus,
gi surgery
If the serum calcium in the range 2.50-2.55 mmol L, inclusion required a serum PTH below 5.0 pmol L-acute psychiatric urgency:
active suicidality,
acute psychosis,
active substance use<6mo or
pregnant or nursing females

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01884844). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.