Clinical trial NCT01323218: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Obstructive Sleep Apnea-hypopnea Syndrome
Keywords: Obstructive sleep apnea-hypopnea syndrome
OSAHS
Vitamin D
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Centre de Recherche en Nutrition Humaine d'Auvergne
name: Centre de Recherche en Nutrition Humaine Rhone-Alpe
name: Laboratoire Crinex
name: Laboratoire Cidelec
First posted: 2011-03-25
Enrollment: 80
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Apnea-hypopnea index (AHI), defined as the average rate of apneas and hypopneas per hour of sleep
timeFrame: at the beginning (day 0) and after 32 days of vitamin D supplementation
Secondary outcomes:
measure: Epworth sleepiness scale
timeFrame: at the beginning (day 0) and after 32 days of vitamin D supplementation
measure: mean arterial oxygen saturation (SaO2) during sleep, time of SaO2<90%, and Nadir of arterial oxygen saturation (Nadir SaO2)
timeFrame: at the beginning (day 0) and after 32 days of vitamin D supplementation
measure: Continuous positive airway pressure measured with a CPAP equipment
timeFrame: at the beginning (day 0) and after 32 days of vitamin D supplementation
measure: Muscular strength measured with handgrip test
timeFrame: at the beginning (day 0) and after 32 days of vitamin D supplementation
measure: Mini Mental Sate Examination, trail making test, Hamilton Anxiety Depression scale, SF36 questionnaire
timeFrame: at the beginning (day 0) and after 32 days of vitamin D supplementation
measure: Inflammatory status : IL6 and high sensitivity C-reactive proteine (hs CRP)
timeFrame: at the beginning (day 0) and after 32 days of vitamin D supplementation
measure: Analysis of genes implicated in vitamin D metabolism
timeFrame: at inclusion.
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
References: