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Completed

NCT Number: NCT02589444

Vitamin D and Microbiota in Cystic Fibrosis

The objective of this study is to assess the effects of a high-dose vitamin D3 on the composition of gut and lung microbiota in adolescents and adults with cystic fibrosis who are vitamin D deficient.

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Key information

Conditions

Vitamin D Deficiency Avitaminosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cystic Fibrosis Deficiency Diseases Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Inflammation Lung Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Pancreatic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emory Clinic

Atlanta, Georgia, 30322, United States

About this study

Monocentric, double-blind, randomized, placebo-controlled, interventional pilot study to investigate the beneficial effects of high dose vitamin D supplementation on gut and lung microbiota in patients with cystic fibrosis who are vitamin D insufficient.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Presenting to the Cystic fibrosis clinic for routine follow up of cystic fibrosis
  • Serum 25(OH)D concentrations obtained within 2 months of enrollment
  • Able to tolerate oral medications

Exclusion criteria

  • Inability to obtain or declined informed consent from the subject and/or legally authorized representative
  • Pregnancy or plans to become pregnant in the next 3 months
  • History of disorders associated with hypercalcemia including parathyroid disease
  • Current hypercalcemia (albumin-corrected serum calcium >10.8 mg/dL or ionized calcium >5.2 mg/dL)
  • History of nephrolithiasis with active symptoms within the past two years
  • Chronic kidney disease worse than stage III (<60 ml/min)
  • Current significant hepatic dysfunction total bilirubin > 2.5 mg/dL with direct bilirubin > 1.0 mg/dL
  • Current use of cytotoxic or immunosuppressive drugs
  • History of AIDS
  • History of illicit drug abuse (defined as history of enrollment into a drug rehabilitation program or hospital visits due to drug use within the past 3 years or any use of the following drugs in the past 6 months (cocaine, opiates, amphetamines, marijuana) or any positive toxicology screen for (cocaine, opiates, amphetamines, marijuana)
  • Too ill to participate in study based on investigator's or study team's opinion
  • Current enrollment in another intervention trial
  • In addition we amended our study with three additional criteria 11) systemic antibiotic use in the last 4 weeks, 12) use of probiotics and, 13) inflammatory bowel disease, four months after the start of the study and after 12 subjects were randomized, as we considered that these factors may also influence our study endpoints. Of the 12 subjects who were randomized, only 4 would have been excluded.

Treatment and study plan

High-Dose Vitamin D3

Dietary Supplement

50,000 IU of oral vitamin D3 once a week (the standard of care for repletion of vitamin D status by the Cystic fibrosis Foundation)

Other names: Cholecalciferol

Stool sample

Other

Participants will be asked to provide a stool sample in a collection container for analysis of stool microbiota. This will be done upon enrollment (baseline) and at 3 month follow-up.

Sputum sample

Other

Participants will be asked to collect their sputum (the thick mucus or phlegm that is expelled from the lower respiratory tract through coughing) into a kit.

This will be done upon enrollment (baseline) and at 3 month follow-up.

Sham Comparator

Other

A placebo capsule taken once a week (manufactured by the same company that makes the Vitamin D supplement).

Other names: Placebo

Blood draw

Procedure

Participants will be asked to provide 30 ml of blood collected via a blood draw to measure 25 (OH)D serum concentration and other nutrient markers related to vitamin D including Parathyroid hormone, fibroblast growth factor-23, vitamin D binding protein and markers of immune system/inflammation. This will be done at baseline and at 3 months follow up.

Primary outcomes

  1. Shannon Index

    Time frame: Change from baseline shannon Index at 3 months after initiation of treatment

    Sputum microbiota analysis will be measured using this ecological diversity measure. Sputum samples will be collected via a sputum kit.

  2. Species Richness Index

    Time frame: Change from baseline Species Richness Index at 3 months after initiation of treatment

    Stool microbiota analysis will be measured using this ecological diversity measure. Stool samples will be collected using a stool kit provided to the participant.

Secondary outcomes

  1. Serum 25(OH)D levels (and other nutritional markers related to vitamin D including nutrient levels, parathyroid hormone, fibroblast growth factor-23, free 25(OH)D, vitamin D binding protein

    Time frame: At baseline and 3 months after initiation of treatment

    Collected via blood draw.

  2. Forced expiratory volume in 1 second (FEV1)

    Time frame: Change in Forced expiratory volume in 1 second( FEV1) at 3 months after initiation of treatment

    Spirometry (is a common office test used to assess how well the participant's lungs work by measuring how much air the participant inhales, how much the participant exhales and how quickly the participant exhales) to assess the impact of vitamin D status on lung function.

    Spirometry results will only be collected if they are done as part of the participants routine care.

  3. Measures of plasma oxidative stress by assessing plasma aminothiol concentrations (glutathione, glutathione disulfide, cysteine, cystine) and their redox potentials.

    Time frame: At baseline and 3 months after initiation of treatment

    Collected via blood draw.

  4. Measures of inflammation by assessing plasma IL-6, TNF-alpha, MCP-1, and IL-8 concentrations

    Time frame: At baseline and 3 months after initiation of treatment

    Collected via blood draw.

  5. Forced vital capacity (FVC)

    Time frame: Change in Forced vital capacity( FVC) at 3 months after initiation of treatment

    Spirometry (is a common office test used to assess how well the participant's lungs work by measuring how much air the participant inhales, how much the participant exhales and how quickly the participant exhales) to assess the impact of vitamin D status on lung function.

    Spirometry results will only be collected if they are done as part of the participants routine care.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Official study title

Pilot Study Evaluating the Role of Vitamin D Repletion on Gut and Lung Microbiota in Cystic Fibrosis

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 28, 2015
Registry last updated
Jun 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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