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Sleep Apnea Syndrome and Vitamin D

Primary Purpose

Obstructive Sleep Apnea-hypopnea Syndrome

Status

Unknown status

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

25 OH vitamin D

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea-hypopnea Syndrome focused on measuring Obstructive sleep apnea-hypopnea syndrome, OSAHS, Vitamin D

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Moderate to severe obstructive sleep apnoea (AHI > 15)
With or without continuous positive airway pressure for a minimum of six months
aged 30-75 years
Vitamin D2D3 level < 30 ng/ml

Exclusion Criteria:

Diseases or therapy known to interfere with phospho-calcium or vitamin D metabolism
Patients with mixed sleep apnoea (central and obstructive)
Patients with CPAP use < 4 hours per night
Patients with maxillofacial or oro-pharyngeal diseases)
Patients with chronic respiratory failure, hypercapnic patients
Muscle diseases
Alcohol intake > 2 glasses per day
Body mass index > 40 kg/m2

Sites / Locations

CHU Clermont-FerrandRecruiting

Outcomes

Primary Outcome Measures

Apnea-hypopnea index (AHI), defined as the average rate of apneas and hypopneas per hour of sleep

Secondary Outcome Measures

Epworth sleepiness scale

mean arterial oxygen saturation (SaO2) during sleep, time of SaO2<90%, and Nadir of arterial oxygen saturation (Nadir SaO2)

Continuous positive airway pressure measured with a CPAP equipment

Muscular strength measured with handgrip test

Mini Mental Sate Examination, trail making test, Hamilton Anxiety Depression scale, SF36 questionnaire

Inflammatory status : IL6 and high sensitivity C-reactive proteine (hs CRP)

Analysis of genes implicated in vitamin D metabolism

Full Information

NCT ID

NCT01323218

First Posted

March 24, 2011

Last Updated

March 24, 2011

Sponsor

University Hospital, Clermont-Ferrand

Collaborators

Centre de Recherche en Nutrition Humaine d'Auvergne, Centre de Recherche en Nutrition Humaine Rhone-Alpe, Laboratoire Crinex, Laboratoire Cidelec

1. Study Identification

Unique Protocol Identification Number

NCT01323218

Brief Title

Sleep Apnea Syndrome and Vitamin D

Official Title

Effect of the Correction of Vitamin D Deficiency in Patients With Obstructive Sleep Apnea-hypopopnea Syndrome (OSAHS)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2011

Overall Recruitment Status

Unknown status

Study Start Date

March 2011 (undefined)

Primary Completion Date

April 2012 (Anticipated)

Study Completion Date

June 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

University Hospital, Clermont-Ferrand

Collaborators

Centre de Recherche en Nutrition Humaine d'Auvergne, Centre de Recherche en Nutrition Humaine Rhone-Alpe, Laboratoire Crinex, Laboratoire Cidelec

4. Oversight

5. Study Description

Brief Summary

Obstructive sleep apnea/hypopnea syndrome (OSAHS) is a highly prevalent disorder with multiple comorbidities. OSAHS is characterized by repetitive episodes of airflow reduction (hypopnoea) or cessation (apnoea) due to upper airway collapse during sleep. Its major risk factor is obesity. However, its pathogenesis is complex and multifactorial. Reduced upper airway muscle tonus and/or unstable neuromuscular output seem to be involved in this collapsus. A normal vitamin D status is necessary for normal muscle function and neuromuscular output. As obesity is associated with a high rate of hypovitaminosis D, it appears of interest to evaluate the effect of vitamin D supplementation on OSAHS patients with vitamin D deficiency.

Detailed Description

Prospective, longitudinal, double bind, randomized study of the effect of vitamin D supplementation in OSAHS patients with hypovitaminosis D. After written informed consent, patients will be randomized to receive a single dose of oral vitamin D (400 000 UI) or placebo. Subjects will undergo medical screening before randomisation into placebo or active group. Follow-up measurements will be performed at the beginning (day 0) and after 32 days of vitamin D supplementation: clinical examination, biological check up and sleep parameter evaluation. Patients will be instructed to stop using continuous positive airway pressure device for two nights before nocturnal sleep studies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obstructive Sleep Apnea-hypopnea Syndrome

Keywords

Obstructive sleep apnea-hypopnea syndrome, OSAHS, Vitamin D

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

25 OH vitamin D

Intervention Description

After written informed consent, patients will be randomized to receive a single dose of oral vitamin D (400 000 UI) or placebo. Subjects will undergo medical screening before randomisation into placebo or active group. Follow-up measurements will be performed at the beginning (day 0) and after 32 days of vitamin D supplementation: clinical examination, biological check up and sleep parameter evaluation. Patients will be instructed to stop using continuous positive airway pressure device for two nights before nocturnal sleep studies

Primary Outcome Measure Information:

Title

Apnea-hypopnea index (AHI), defined as the average rate of apneas and hypopneas per hour of sleep

Time Frame