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Sleep Apnea Syndrome and Vitamin D

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ClinicalTrials.gov Identifier: NCT01323218
Recruitment Status : Unknown
Verified March 2011 by University Hospital, Clermont-Ferrand.
Recruitment status was:  Recruiting
First Posted : March 25, 2011
Last Update Posted : March 25, 2011
Sponsor:
Collaborators:
Information provided by:

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.


Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea-hypopnea Syndrome Drug: 25 OH vitamin D Phase 2

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of the Correction of Vitamin D Deficiency in Patients With Obstructive Sleep Apnea-hypopopnea Syndrome (OSAHS)
Study Start Date : March 2011
Estimated Primary Completion Date : April 2012
Estimated Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Drug: 25 OH vitamin 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

Outcome Measures

Primary Outcome Measures :
  1. Apnea-hypopnea index (AHI), defined as the average rate of apneas and hypopneas per hour of sleep [ Time Frame: at the beginning (day 0) and after 32 days of vitamin D supplementation ]

Secondary Outcome Measures :
  1. Epworth sleepiness scale [ Time Frame: at the beginning (day 0) and after 32 days of vitamin D supplementation ]
  2. mean arterial oxygen saturation (SaO2) during sleep, time of SaO2<90%, and Nadir of arterial oxygen saturation (Nadir SaO2) [ Time Frame: at the beginning (day 0) and after 32 days of vitamin D supplementation ]
  3. Continuous positive airway pressure measured with a CPAP equipment [ Time Frame: at the beginning (day 0) and after 32 days of vitamin D supplementation ]
  4. Muscular strength measured with handgrip test [ Time Frame: at the beginning (day 0) and after 32 days of vitamin D supplementation ]
  5. Mini Mental Sate Examination, trail making test, Hamilton Anxiety Depression scale, SF36 questionnaire [ Time Frame: at the beginning (day 0) and after 32 days of vitamin D supplementation ]
  6. Inflammatory status : IL6 and high sensitivity C-reactive proteine (hs CRP) [ Time Frame: at the beginning (day 0) and after 32 days of vitamin D supplementation ]
  7. Analysis of genes implicated in vitamin D metabolism [ Time Frame: at inclusion. ]

Eligibility Criteria

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

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): NCT01323218


Contacts
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
France
CHU Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Centre de Recherche en Nutrition Humaine d'Auvergne
Centre de Recherche en Nutrition Humaine Rhone-Alpe
Laboratoire Crinex
Laboratoire Cidelec
More Information

Responsible Party: Patrick LACARIN, CHU Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01323218     History of Changes
Other Study ID Numbers: CHU-0091
First Posted: March 25, 2011    Key Record Dates
Last Update Posted: March 25, 2011
Last Verified: March 2011

Keywords provided by University Hospital, Clermont-Ferrand:
Obstructive sleep apnea-hypopnea syndrome
OSAHS
Vitamin D

Additional relevant MeSH terms:
Syndrome
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Disease
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents