Effect of vitamin D in improvement of depression

• Register: IRCT
• Last refreshed on: 22 February 2018
• Main ID: IRCT2014080315276N2
• Date of registration: 2014-09-05
• Prospective Registration: Yes
• Primary sponsor: Vice chancellor for research, Tehran University of Medical Sciences
• Public title: Effect of vitamin D in improvement of depression
• Scientific title: Evaluating the effect of vitamine D in improvement rate of 18-65 years old patients with treatment resistant depression in ziaeian hospital in 2014
• Date of first enrolment: 2014-09-06
• Target sample size: 64
• Recruitment status: Complete
• URL: http://en.irct.ir/trial/14573
• Study type: interventional
• Study design: Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.
• Phase: 2-3

Countries of recruitment

Iran (Islamic Republic of)

Contacts

• Name: Mohammad Effatpanah
• Affiliation: Tehran University of Medical Sciences

• Name: Mohammad Effatpanah
• Affiliation: Tehran University of Medical Sciences

Key inclusion & exclusion criteria

Inclusion criteria: Inclusion criteria: 18-65 year old patients with treatment resistant depression based on survey by psychologist and DSM IV criteria. The patients
who entered the study must be known case of major depression disorder and under treatment with full dose Sertraline at least 4-6 weeks and not responding to treatment. Also their 25-hydroxyvitamin D serum level must be lower than 50 nmol/L or less than 20 ng/ml. Women of reproductive age with negative BHCG that use reliable method of contraception during the study.
Exclusion criteria: patients with Sarcoidosis, Tuberculosis, Malignancy, Hypercalcemia, Renal disease (Nephrolithiasis, etc.); known case of malabsorption problems like celiac and etc. and other medical or psychiatric illnesses associated. Pregnant or lactating women are also excluded.
Exclusion criteria:

Age minimum: 18 years
Age maximum: 65 years
Gender: Both

Health Condition(s) or Problem(s) studied

F32.1, F32

Condition 1: Treatment – Resistant Depression. Condition 2: Vitamin D deficiency.
Severe depressive episode without psychotic symptoms and Moderate depressive episode
Vitamin D deficiency

Severe depressive episode without psychotic symptoms and Moderate depressive episode

Vitamin D deficiency

Intervention(s)

Bupropion 450 mg tablet, daily, oral, up to 3 month + Calcium carbonate 500 mg tablet,oral, BD, up to 3 month + vitamin D3 pearl oral, one perl per week up to 8 weeks and then one perl per month up to 4 month for intervention group.

Intervention 1: Bupropion 450 mg tablet, daily, oral, up to 3 month + Calcium carbonate 500 mg tablet,oral, BD, up to 3 month + vitamin D3 pearl oral, one perl per week up to 8 weeks and then one perl per month up to 4 month for intervention group. Intervention 2: Bupropion 450 mg tablet, daily, oral, up to 3 month + Calcium carbonate 500 mg tablet,oral, BD, up to 3 month + Placebo vitamin D3 pearl oral, one perl per week up to 8 weeks and then one perl per month up to 4 month for control group.

Placebo

Bupropion 450 mg tablet, daily, oral, up to 3 month + Calcium carbonate 500 mg tablet,oral, BD, up to 3 month + Placebo vitamin D3 pearl oral, one perl per week up to 8 weeks and then one perl per month up to 4 month for control group

Treatment - Drugs

Primary Outcome(s)

The degree of depression based on Hamilton Depression Rating scale. Timepoint: Once before and once after three months of initial intervention. Method of measurement: Hamilton Depression Rating scale.

Secondary Outcome(s)

Parathyroid hormoneserum level mmol/L or mg/dl. Timepoint: Once before and once after three months of initial intervention. Method of measurement: Blood sample taking.

25-hydroxyvitamin D serum level nmol/L or ng/ml. Timepoint: Once before and once after three months of initial intervention. Method of measurement: Blood sample taking.

Calcium serum level mg/dl or mM. Timepoint: Once before and once after three months of initial intervention. Method of measurement: Blood sample taking.

Age. Timepoint: Once before initial intervention. Method of measurement: Observation.

Phosphorus serum level mmol/L or mg/dl. Timepoint: Once before and once after three months of initial intervention. Method of measurement: Blood sample taking.

Sex. Timepoint: Once before initial intervention. Method of measurement: Observation.

Source(s) of Monetary Support

Vice chancellor for research, Tehran University of Medical Sciences

Ethics review

Status: Approved
Approval date:
Contact:

Ethics committee of Tehran University of Medical Sciences