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Creatine Monohydrate Use for Preventing Altitude Induced Depression

Sponsor
Mike O'Callaghan Military Hospital (U.S. Fed)
Overall Status
Withdrawn
CT.gov ID
NCT03433651
Collaborator
(none)
0
Enrollment
1
Location
2
Arms
6
Actual Duration (Days)
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study involves the use of an investigational drug called Creatine Monohydrate. This means that the drug has not yet been approved by the Food & Drug Administration (FDA) for treatment of altitude-induced depression. However, the FDA has not objected to its use to study its safety and effectiveness for preventing altitude-induced depression. This study will help find out what effects, good and/or bad, Creatine Monohydrate has on treating symptoms for altitude-induced depression. Creatine Monohydrate is believed to have an effect on improving symptoms of depression. The safety of Creatine Monohydrate in humans has been tested in prior research studies; however, some side effects may not yet be known.

Condition or Disease Intervention/Treatment Phase
  • Drug: Creatine monohydrate
  • Drug: Placebo
 Phase 4

Detailed Description

Subjects will be in this research study if they moved to Creech AFB from an elevation of less than 2.000 feet within the last month. The purpose of this study is to see if creatine monohydrate is effective in preventing altitude-induced depression. This study will enroll approximately 75 subjects.

This study involves the use of an investigational drug called Creatine Monohydrate. This means that the drug has not yet been approved by the Food & Drug Administration (FDA) for treatment of altitude-induced depression. However, the FDA has not objected to its use to study its safety and effectiveness for preventing altitude-induced depression. This study will help find out what effects, good and/or bad, Creatine Monohydrate has on treating symptoms for altitude-induced depression. Creatine Monohydrate is believed to have an effect on improving symptoms of depression. The safety of Creatine Monohydrate in humans has been tested in prior research studies; however, some side effects may not yet be known.

Creatine Monohydrate is a dietary supplement that is believed to aid in the building of muscle mass.

The placebo being used in this study is Maltodextrin (a sugar). Maltodextrin is an FDA approved food additive made from a highly processed starch product typically made from corn.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Masking Description:
Subjects will be randomized using a random number generator to receive either creatine monohydrate or a placebo for 90 days. Both subjects and investigators will be blinded to the study group assignments
Primary Purpose:
Treatment
Official Title:
Creatine Monohydrate Use for Preventing Altitude Induced Depression
Actual Study Start Date :
Jan 1, 2019
Actual Primary Completion Date :
Jan 7, 2019
Actual Study Completion Date :
Jan 7, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: creatine monohydrate

Experimental will take by mouth 5 grams a day of creatine monohydrate powder. Subjects will be given a 30 day supply of the study powder. They will be reminded to take the powder as instructed.

Drug: Creatine monohydrate
Subjects will take by mouth 5 grams a day of creatine monohydrate powder.
Other Names:
  • creapure

    		•
    Placebo Comparator: Placebo

    Placebo will take by mouth 5 grams a day of placebo powder. Subjects will be given a 30 day supply of the study powder. They will be reminded to take the powder as instructed.

    Drug: Placebo
    Subjects will take by mouth 5 grams a day of placebo powder.
    Other Names:
  • maltodextrin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Patient Health Questionnaire-9 (PHQ-9) [5 repeated measurements over the 120-day course of the study]

      Questionnaire

    2. Generalized Anxiety Disorder 7 (GAD-7) [5 repeated measurements over the 120-day course of the study]

      Questionnaire

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    PATIENTS MUST BE ABLE TO GET CARE AT NELLIS AIR FORCE BASE (A MILITARY INSTALLATION) IN ORDER TO PARTICIPATE IN THIS STUDY

    Inclusion Criteria:

    • Male and Female Active Duty members and DoD beneficiaries ages 18-65

    • Moved to CREECH AFB from an altitude of less than 2,000 feet within the last month

    Exclusion Criteria:

    • Preexisting depression as noted in a review of their medical record or on their PHQ9 (score of 10 or greater)

    • Preexisting anxiety as noted in a review of their medical record or on their GAD 7 (score of 10 or greater)

    • Clinical or laboratory evidence of liver disease.

    • Serum creatinine >1.5

    • Existing kidney disease

    • Existing Type I or Type II Diabetes Mellitus

    • Taking creatine as a dietary supplement

    • Moved to CREECH AFB from an altitude of greater than 2000 feet

    • Pregnant, breast feeding, or trying to become pregnant

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mike O'Callaghan Military Medical Center Las Vegas Nevada United States 89191

    Sponsors and Collaborators

    • Mike O'Callaghan Military Hospital

    Investigators

    • Principal Investigator: Lee Church, MD, Mike O'Callaghan Military Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Mike O'Callaghan Military Hospital
    ClinicalTrials.gov Identifier:
    NCT03433651
    Other Study ID Numbers:
    • FWH20180039H
    First Posted:
    Feb 14, 2018
    Last Update Posted:
    Jan 9, 2019
    Last Verified:
    Jan 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Mike O'Callaghan Military Hospital
    depression
    Additional relevant MeSH terms:
    Depression
    Depressive Disorder

    Study Results

    No Results Posted as of Jan 9, 2019