Trial Outcomes & Findings for Vitamin D Supplementation for Bipolar Depression (NCT NCT01884844)

Last Updated: 2018-06-19

Results Overview

Montgomery-Åsberg Depression Rating Scale Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. The questionnaire includes questions on the following symptoms 1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts Usual cutoff points are: 0 to 6 - normal/symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression \>34 - severe depression.

Recruitment status

COMPLETED

Study phase

Target enrollment

33 participants

Primary outcome timeframe

baseline and at 12 week completion

Results posted on

2018-06-19

Participant Flow

Participant milestones

Participant milestones
Measure	Vitamin D3 Vitamin D3, Cholecalciferol, 5000IU po qday for 12 weeks Vitamin D3, Cholecalciferol	Placebo methylcellulose po qday for 12weeks Placebo
Overall Study STARTED	16	17
Overall Study COMPLETED	13	12
Overall Study NOT COMPLETED	3	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vitamin D Supplementation for Bipolar Depression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vitamin D3 n=16 Participants Vitamin D3, Cholecalciferol, 5000IU po qday for 12 weeks Vitamin D3, Cholecalciferol	Placebo n=17 Participants methylcellulose po qday for 12weeks Placebo	Total n=33 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants	17 Participants n=7 Participants	33 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	45.2 years STANDARD_DEVIATION 13.3 • n=5 Participants	43.3 years STANDARD_DEVIATION 12.9 • n=7 Participants	44.2 years STANDARD_DEVIATION 13.1 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	10 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	7 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants	17 participants n=7 Participants	33 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and at 12 week completion

Population: Comparison of bimonthly scale measurements (MADRS, between treatment groups over time were done fitting individual Generalized Linear Models (GLMs) using the initial baseline measurement as an adjustment. Significance was fixed at 0.05%. SPSS v. 23 used

Outcome measures

Outcome measures
Measure	Vitamin D3 n=12 Participants Vitamin D3, Cholecalciferol, 5000IU po qday for 12 weeks Vitamin D3, Cholecalciferol	Placebo n=13 Participants methylcellulose po qday for 12weeks Placebo
Change in Montgomery-Åsberg Depression Rating Scale	9.4 units on a scale Interval 3.5 to 15.6	6.4 units on a scale Interval 2.3 to 10.6

Adverse Events

Vitamin D3

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Vitamin D3 n=16 participants at risk Vitamin D3, Cholecalciferol, 5000IU po qday for 12 weeks Vitamin D3, Cholecalciferol	Placebo n=17 participants at risk methylcellulose po qday for 12weeks Placebo
Gastrointestinal disorders xerostomia	25.0% 4/16 • 12weeks of study	17.6% 3/17 • 12weeks of study
Gastrointestinal disorders appetite decrease	18.8% 3/16 • 12weeks of study	11.8% 2/17 • 12weeks of study
Gastrointestinal disorders diarhea	12.5% 2/16 • 12weeks of study	11.8% 2/17 • 12weeks of study
General disorders weakness	23.1% 3/13 • 12weeks of study	17.6% 3/17 • 12weeks of study
General disorders mild confustion	15.4% 2/13 • 12weeks of study	11.8% 2/17 • 12weeks of study
Nervous system disorders headache	23.1% 3/13 • 12weeks of study	5.9% 1/17 • 12weeks of study
General disorders mild sedation	18.8% 3/16 • 12weeks of study	11.8% 2/17 • 12weeks of study
Reproductive system and breast disorders sexual dysfunction, any	12.5% 2/16 • 12weeks of study	11.8% 2/17 • 12weeks of study

Additional Information

Director of the Bipolar Disorders Specialty Clinic

Department of Psychiatry, Universtity of Massachusetts

Phone: 508-334-5052

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place