Effect of vitamin D in improvement of depressio

Phase 2

Conditions: Condition 1: Treatment – Resistant Depression. Condition 2: Vitamin D deficiency.
Severe depressive episode without psychotic symptoms and Moderate depressive episode
Vitamin D deficiency
F32.1, F32

Registration Number: IRCT2014080315276N2

Lead Sponsor: Vice chancellor for research, Tehran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 64

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

Not provided

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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.;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.;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.;Age. Timepoint: Once before initial intervention. Method of measurement: Observation.;Sex. Timepoint: Once before initial intervention. Method of measurement: Observation.