Determining the Pharmacokinetics of Oral Creatine in Human Pregnancy

Not Applicable

• Conditions: The pharmacokinetics of oral creatine monohydrate (CrM) dosing in pregnancy; Metabolism of nutraceutical supplement (creatine monohydrate) in pregnancy; Diet and Nutrition - Other diet and nutrition disorders

• Registration Number: ACTRN12620001373965
• Lead Sponsor: Monash Medical Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-22
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

=/>18 years of age.
English speaking and able to give written informed consent
No known renal, hepatic, or cardiovascular symptoms.
No known gastrointestinal (GIT) disorders affecting absorption from GIT
Not consuming known dietary or nutritional supplements containing creatine or protein-based powders
BMI <35
Pregnant women only; between 30-34 weeks gestation birthing at the tertiary centre where the trial is being conducted so birthing outcomes can be assessed

Exclusion Criteria

<18 years of age
Poor English skills or not proficient in reading English
Diabetes Type 1 or 2
Known renal disease/hepatic disease
Known cardiovascular disease or risk factors for cardiovascular disorders
No colitis or any disease affecting absorption and function of the GIT system
Taking supplements that may contain creatine or other amino acids
BMI >35
Different model of care (not birthing at tertiary centre)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quantitative analysis of plasma creatine concentrations.<br>[Blood samples will be taken at baseline (0), 30 mins, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, and 10 hours after oral administration of creatine monohydrate in Stage 1 & Stage 2. ];Tolerability profile and safety[Participants will be assessed at the same intervals as sample collection over the 10 hour period post-intervention for any changes from baseline, including polydipsia, headache, swelling, stomach discomfort, muscle cramps, blurry vision or nausea. These will be changes identified in the participant, either reported by the participant, or observed by the researcher. Any change will be documented and acted upon appropriately. For Stage 1 and 2, participants will be phoned within a 24-hour period (one day post-intervention) to determine if any changes occurred over the subsequent 12-14-hour period post-study completion. Participants will be reviewed in person on each day of the Stage 3 trial intervention.]