Sleep Apnea Syndrome and Vitamin D

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by University Hospital, Clermont-Ferrand.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Centre de Recherche en Nutrition Humaine d'Auvergne
Centre de Recherche en Nutrition Humaine Rhone-Alpe
Laboratoire Crinex
Laboratoire Cidelec
Information provided by:
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01323218
First received: March 24, 2011
Last updated: NA
Last verified: March 2011
History: No changes posted
  Purpose

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 Intervention Phase
Obstructive Sleep Apnea-hypopnea Syndrome
Drug: 25 OH vitamin D
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effect of the Correction of Vitamin D Deficiency in Patients With Obstructive Sleep Apnea-hypopopnea Syndrome (OSAHS)

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Epworth sleepiness scale [ Time Frame: at the beginning (day 0) and after 32 days of vitamin D supplementation ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Continuous positive airway pressure measured with a CPAP equipment [ Time Frame: at the beginning (day 0) and after 32 days of vitamin D supplementation ] [ Designated as safety issue: Yes ]
  • Muscular strength measured with handgrip test [ Time Frame: at the beginning (day 0) and after 32 days of vitamin D supplementation ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Analysis of genes implicated in vitamin D metabolism [ Time Frame: at inclusion. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: March 2011
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
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
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

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Patrick LACARIN, CHU Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01323218     History of Changes
Other Study ID Numbers: CHU-0091
Study First Received: March 24, 2011
Last Updated: March 24, 2011
Health Authority: France: Ministry of Health

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

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

ClinicalTrials.gov processed this record on October 01, 2014