Effect of supplementation in treatment of maintenance methadone treatment patients

Clinical trial of the effect of vitamin D supplementation compared with the placebo on mental health parameters and metabolic profiles in maintenance methadone treatment patients

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT201701035623N102

Enrollment

Registered

2017-01-08

Start date

2016-09-29

Completion date

Unknown

Last updated

2019-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Addiction. Mental and behavioural disorders due to psychoactive substance use

Interventions

Intervention 1: Intervention group: 50000 IU vitamin D (Zahravi, Tabriz, Iran), once every 2 weeks, for 12 weeks orally. Intervention 2: Control group: Placebo (Barij Essence, Kashan, Iran), once ever

Eligibility

Sex/Gender

All

Age

25 Years to 70 Years

Inclusion criteria

Inclusion criteria: Patients of methadone maintenance treatment Aged 25 to 70 years Informed consent from all patients

Exclusion criteria

Exclusion criteria: Taking vitamin D, multivitamin-mineral and antioxidant supplements during 3 months before the intervention Taking anti-inflammatory agents Patients with history of metabolic disorders

Design outcomes

Primary

Measure	Time frame
Depression. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Beck Depression Inventory (BDI).;Anxiety. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Beck Anxiety Inventory (BAI).;Sleep quality. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Pittsburgh Sleep Quality Index (PSQI).	—

Measure

Time frame

Depression. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Beck Depression Inventory (BDI).;Anxiety. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Beck Anxiety Inventory (BAI).;Sleep quality. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Pittsburgh Sleep Quality Index (PSQI).

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Secondary

Measure	Time frame
Fasting plasma glucose. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Insulin. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;Triglycerides. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Total cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;HDL. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Hs-CRP. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;Total antioxidant. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Glutathione. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Malondialdehyde. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.	—

Measure

Time frame

Fasting plasma glucose. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Insulin. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;Triglycerides. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Total cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;HDL. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Hs-CRP. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;Total antioxidant. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Glutathione. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Malondialdehyde. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactZatollah Asemi

Kashan University of Medical Sciences

asemi_r@yahoo.com+98 31 5562 0608

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026