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IRCT20240814062762N1 IRCT 2024-08-31 the Iran Center for Dermatology and Hair Research. The effects of creatine supplementation on male pattern baldness in male resistance athletes Investigating the effects of creatine supplementation on serum testosterone, dihydrotestosterone levels, and hair density in strength athletes: A double-blind clinical trial study 2024-10-01 anticipated 45 Complete https://irct.ir/trial/78558 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study, participants are randomly assigned to two groups: the intervention group (receiving creatine) and the control group (receiving a placebo). To ensure accuracy and reliability in this process, standard randomization methods have been employed. For example, the researchers have utilized computer software to generate random numbers, which determines the group assignment for each participant. These methods guarantee that the allocation of participants to groups is entirely random, with no bias or influence from external factors. In this study, no quasi-random methods, such as assignment based on birth date, odd or even numbers, or any predetermined pattern, have been used. Such methods are considered non-random allocation and do not provide the same level of validity as full randomization. Overall, to maintain scientific rigor and minimize bias, the researchers have ensured that the assignment of participants to the intervention and control groups is carried out completely randomly, using validated randomization methods, Blinding description: In this study, blinding has been carefully designed to ensure that several groups involved are unaware of the allocation to the intervention and control groups: Participants: The participants are unaware of whether they have been assigned to the intervention group (receiving creatine) or the control group (receiving a placebo). This blinding is achieved by using supplement and placebo capsules that are identical in appearance, with no distinguishable differences for the participants. Principal Investigator: The principal investigator, responsible for the overall management of the study, is also blinded to the participants' group assignments. This blinding is implemented to prevent any bias in the interpretation and analysis of the data. These blinding procedures are crucial for maintaining the scientific integrity of the study and minimizing any potential bias throughout the research process. It is important to note that participants are fully informed about their involvement in the study, and adequate information has been provided to them. The lack of awareness regarding group allocation does not imply that participants are unaware of their participation in the study, and it does not in any way violate ethical research principles. 1 Hairloss. Intervention 1: Intervention group: Participants in the intervention group will receive a daily standard dose of creatine supplement. This dosage is determined based on common and safe guidelines for creatine consumption in athletes. Intervention 2: Control group: Participants in the control group will receive a daily standard dose of a placebo supplement containing 5 grams of maltodextrin. Yes - There is a plan to make this available What will be shared: Individual Participant Data: Description: Individual participant data, including demographic information, hormonal test results, and hair loss assessments. Data Sharing Details: These data will be shared after full anonymization (removal of any personally identifiable information). Only data related to primary outcomes (such as hair density and hormonal changes) will be shared. Statistical Analysis Results: Description: Files containing statistical analysis results related to the effects of creatine supplementation on the study's primary outcomes. Data Sharing Details: These data will be shared in full and without any restrictions, making them accessible to researchers and the scientific community. Study Protocol: Description: The complete study protocol, including methods, design, and inclusion/exclusion criteria. Data Sharing Details: This protocol will be shared after the study's completion and will be made available for use by other researchers. Reports Related to Secondary Outcomes: Description: Information and results related to secondary outcomes, such as minor changes in other health parameters. Data Sharing Details: This information will be shared selectively, based on requests from other researchers. When: After Study Completion To whom: University Professors, Researchers Conditions: If it can be useful for future studies and provide guidance for them Where to obtain: Send an email to Yasinlakifbb@yahoo.com How to obtain: Send an email Formal request Receive documents Comments:
public Mohammadyasin Lak
Unit 4, No. 15, Corner of 3rd Alley, Shahrara, Sattarkhan, Tehran, Iran
Tehran Iran (Islamic Republic of) 1443793120 +98 21 6690 1745 yasinlakifbb@gmail.com the Iran Center for Dermatology and Hair Research. scientific Mohammadyasin Lak
Unit 4, No. 15, Corner of 3rd Alley, Shahrara, Sattarkhan, Tehran, Iran
Tehran Iran (Islamic Republic of) 1443793113 +98 21 6690 1745 yasinlakifbb@gmail.com Sport sciences research institute Iran (Islamic Republic of) General Health Status: Healthy individuals without chronic diseases or metabolic disorders. Male Pattern Baldness: Participants must not exhibit early signs of male pattern baldness (androgenetic alopecia). Sporting Activity: Individuals must have been regularly engaged in resistance training (e.g., bodybuilding) for at least one year. No Recent Supplement Use: Individuals must not have used any creatine supplements or hair loss-related medications (such as finasteride or minoxidil) for at least one month prior to the study. 18 years 40 years Male History of Hair-Related Diseases: Individuals with skin diseases or other conditions that could affect hair loss, such as alopecia areata. Current Medication or Supplement Use: Current users of medications affecting hormones or other supplements related to hair loss. Advanced Hair Loss: Individuals with advanced hair loss (Norwood stage 5 or above), which could complicate study outcomes. Lifestyle Placebo Intervention group: Participants in the intervention group will receive a daily standard dose of creatine supplement. This dosage is determined based on common and safe guidelines for creatine consumption in athletes. Control group: Participants in the control group will receive a daily standard dose of a placebo supplement containing 5 grams of maltodextrin. Change in hair density based on counting the number of hair strands in a specific area of the scalp, using standard imaging techniques at different time points (before the intervention and three months after the intervention). Timepoint: before the intervention and three months after the intervention. Method of measurement: using standard imaging techniques. Changes in serum hormone levels: Measurement of changes in testosterone, dihydrotestosterone (DHT), and other related hormones at different time points throughout the study.Hair loss rate: Assessment of the extent of hair loss using standard imaging techniques in specific areas of the scalp, conducted at various time intervals before and after the intervention. Timepoint: After 3 months. Method of measurement: Use of standard imaging techniques/blood tests. the Iran Center for Dermatology and Hair Research. Approved 2024-01-14 Ethics Committee/Research Ethics Working Group of the Schools of Health, Nutrition, and Food Science Karimkhan Zand Boulevard, Shiraz, Fars Shiraz Fars Iran (Islamic Republic of)