Health TrialsbyHealthPanel

Nutrition Supplement for Cystic Fibrosis

ConditionCystic Fibrosis (CF)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorOhio State University

About this trial

The goal of this study is to learn if one nutrition supplement formula works better than a different formula in adults with cystic fibrosis. The main question being addressed is: Will certain atypical versions of certain nutrients outperform typical versions of these nutrients? This will be determined by examining blood measures of nutrient levels and/or indications of nutrient function indicators pre- and post-intervention. Participants will take the supplements for 6 weeks with a blood draw before and after that time.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosed with cystic fibrosis

Diagnosed with exocrine pancreatic insufficiency

18 years old or older

Currently on modulator

Disqualifiers

Non-English-speaking participants

Acute health crisis

Persistent elevation of liver enzymes >6 months (E2) (ALT >80 U/L)

History of liver abnormalities

Trial design

Design model

Parallel

Treatments tested in this trial

  • Common form supplementation

    Dietary supplement

    The intervention product would represent part of a typical supplement given to people including those with CF

  • Uncommon nutrient supplementation

    Dietary supplement

    The intervention product would represent part of a possible new supplement given to people including those with CF

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Conventional nutrient formsActive comparator 1 intervention
Group B: Non-common nutrient formsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Nutrient status assessor 1

Plasma concentrations of 25-OH vitamin D (ng/ml)

Time frame
From pre-supplementation to 6 weeks later
2

Nutrition status assessor 2

Plasma concentrations of vitamin E (mg/L)

Time frame
From pre-supplementation to 6 weeks later
3

Nutrition status assessor 3

Plasma concentrations of CoQ10 (mg/L)

Time frame
From pre-supplementation to 6 weeks later
4

Nutrition status assessor 4

Plasma copper (µg/ml)

Time frame
From pre-supplementation to 6 weeks later

Secondary outcomes

1

Functional implication indicator 1

Plasma glucose(mg/dL)

Time frame
From pre-supplementation to 6 weeks later
2

Functional implication indicator 2

Plasma oxidized LDL (ng/ml)

Time frame
From pre-supplementation to 6 weeks later
3

Functional implication indicator 3

Plasma alanine amino transferase (ALT)(Units/L)

Time frame
From pre-supplementation to 6 weeks later
4

Functional implication indicator 4

Plasma vitamin C-like reducing power (mg ascorbic acid equivalents/dL)

Time frame
From pre-supplementation to 6 weeks later

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ohio State University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: