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Vitamin D, SSRIs and the Musculoskeletal System

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ClinicalTrials.gov Identifier: NCT01932931
Recruitment Status : Completed
First Posted : August 30, 2013
Last Update Posted : January 11, 2018
Sponsor:
Collaborator:
Aalborg University Hospital
Information provided by (Responsible Party):
Stine Aistrup Eriksen, Aalborg University

Brief Summary:

In recent years it has become evident that some types of antidepressants are associated both with an increased risk of falling and decreased bone mineral density. These factors predispose patients for serious fractures such as hip fractures with substantial morbidity and mortality. The specific mechanisms involved in this negative impact on bone and postural control have not been fully elucidated. It is well known that Vitamin D plays an important role for bone health as well as muscle function and thus indirectly postural control. Furthermore, vitamin D deficiency has been observed among depressed patients. To our knowledge no study has investigated the involvement of Vitamin D in relation to the increased risk of fractures associated with antidepressants. Therefore, this project will investigate the underlying mechanisms leading to skeletal impairment and musculoskeletal symptoms in patients receiving different types of antidepressants. Moreover, the effect of vitamin D supplementation will be investigated among patients taking these antidepressants.

150 subjects will participate in this study: 50 of which is diagnosed with depression and receive Citalopram (SSRIs); 50 depressed subjects receiving Mirtazapine(NaSRI); and 50 controls. Through randomisation half of the subjects in each group will receive daily Vitamin D supplementation for a period of one year. Through this period all 150 subjects will be followed through different measurements including bone density, muscle function and balance, nociception, quality of life and depression severity.

It is expected that results from this study will provide increasing awareness and knowledge of the side effect profile of antidepressants on bone metabolism. This may prompt clinicians to screen patients at high risk of drug-induced osteopenia or osteoporosis and accordingly provide treatment, which may reduce the incidence of potentially avoidable fractures. Moreover, some types of antidepressants may show to produce a minimal or even no effect on bone turnover, and should be considered as first line treatment in the group of patients at risk of fractures.


Condition or disease Intervention/treatment Phase
Major Depression Osteoporosis Dietary Supplement: cholecalciferol (50ug) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Two models are used, both a cross sectional study and a RCT. Corss sectional study: Patients (n=21) treated with citalopram (SSRI) due to major depressive disorder (MDD) are investigated for changes in bone mineral density, physcial performance (muscle strength, mobility, and balance), and pain sensitivity when compared to healthy controls (n=50).

RCT: Half of the patients and half of the controls are randomised (by double-blinding) to recieve either high dose vitamin D supplementation (2000 IU/day) of placebo for 12 months. All the primary endpoints from the cross sectional study will be assessed again after 6 and 12 months.

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Vitamin D supplementation and placebo are given as tablets, manufactured by the same company, and with equal size, shape, and taste.
Primary Purpose: Prevention
Official Title: Depression - Can Vitamin D Alleviate Symptoms of Depression Not Cured by Antidepressants as Well as Alleviate Negative Skeletal Effects Caused by Antidepressants?
Actual Study Start Date : October 1, 2013
Actual Primary Completion Date : February 28, 2015
Actual Study Completion Date : September 1, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Cholecalciferol supplement (50ug)
Cholecalciferol supplement is given for 1 year through randomisation of both MDD patients and healthy controls.
Dietary Supplement: cholecalciferol (50ug)
The aim of the study was to investigate the effect of high dose vitamin D3 supplementation on the muscoloskeletal system among patients treated with antidepressants due to a diagnosis of major depressive disorder
Other Name: Vitamin D3 supplement

Placebo Comparator: Placebo
Placebo treatment (tablet) is given for 1 year through randomisation of both MDD patients and healthy controls.
Dietary Supplement: cholecalciferol (50ug)
The aim of the study was to investigate the effect of high dose vitamin D3 supplementation on the muscoloskeletal system among patients treated with antidepressants due to a diagnosis of major depressive disorder
Other Name: Vitamin D3 supplement




Primary Outcome Measures :
  1. Vitamin D [ Time Frame: baseline, 6 months and 1 year ]
    Change in Vitamin D

  2. Bone Mineral Density (DXA) [ Time Frame: baseline and 1 year ]
    change in Bone Mineral Density measured through bone scans of hip and spine (DXA)


Secondary Outcome Measures :
  1. muscle function [ Time Frame: baseline, 6 months and 1 year ]
    Timed up and go, chair stand, isomeric handgrip exercise and postural control/balance (force plate measure with and without eyes closed, and standing on firm/soft underlay)

  2. pain sensitivity [ Time Frame: baseline, 6 months and 1 year ]
    pain induced through deep muscle pain (cuff algometry) and superficial dermal pain (thermal)

  3. Quality of life [ Time Frame: baseline, 6 months and 1 year ]
    two questionnaires: SF-36 and SYSDIET-intervention 2009

  4. Degree of depression [ Time Frame: baseline, 6 months and 1 year ]
    Assessed by Hamilton depression scale (HAM-D)



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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Current Citalopram or Mirtazapine users < 6 months, or individuals who are going to initiate treatment of either Citalopram, Mirtazapine within the following two months or
  • Healthy controls, i.e. not depressed or receiving antidepressants

Exclusion Criteria:

  • Current or use within the past 6 months of drugs which affects bone turnover such as corticosteroids, hormone replacement therapy in postmenopausal women, drugs against osteoporosis or other bone diseases (Paget's disease of bone), vitamin D supplementation (>35 micrograms daily), Depot Medroxyprogesterone Acetate (DMPA), Cyclosporine (CsA), Antiretroviral Therapy (ART)
  • Impaired renal function (serum creatinine > 150 micromolar/l)
  • Pregnant women
  • Individuals diagnosed with cancer or a metabolic disorder such as diabetes
  • Individuals with prosthetic material in hip or spine
  • Individuals diagnosed with a disease that affects bone such as Paget's disease of the bone, or fibrous dysplasia
  • Individuals which is not considered eligible for the clinical trial e.g. individuals diagnosed with dementia, severely psychotic or depressed individuals
  • Individuals that have been taking any kind of antidepressants more than 6 months prior to the inclusion and if this treatment persisted for a period of minimum 12 months
  • Individuals which cannot stand up and stand still without support or a helping device due to physically impairment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01932931


Locations
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Denmark
Aalborg University
Aalborg, North Jutland, Denmark, 9000
CCBR
Aalborg, North Jutland, Denmark, 9000
Sponsors and Collaborators
Aalborg University
Aalborg University Hospital
Investigators
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Study Chair: Peter Vestergaard, Professor, PhD Dr. med Aalborg University
Study Director: Jakob Starup Linde, Dr. med and Phd student Aalborg University
Principal Investigator: Stine A Eriksen, cand.scient.med, Phd student Aalborg University
Publications:

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Responsible Party: Stine Aistrup Eriksen, cand.scient.med and PhD student, Aalborg University
ClinicalTrials.gov Identifier: NCT01932931    
Other Study ID Numbers: N-20130052
First Posted: August 30, 2013    Key Record Dates
Last Update Posted: January 11, 2018
Last Verified: January 2018
Keywords provided by Stine Aistrup Eriksen, Aalborg University:
Vitamin D
Major depression
SSRIs
Osteoporosis
Additional relevant MeSH terms:
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Osteoporosis
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Vitamin D
Cholecalciferol
Vitamins
Micronutrients
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents