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Dietary Supplement

Clinical Data for Breastfeeding

Phase 1
Waitlist Available
Research Sponsored by Texas Woman's University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up six weeks
Awards & highlights

Study Summary

This trial aims to compare the effectiveness of using extra-virgin coconut oil versus Highly Purified Anhydrous (HPA) Lanolin in reducing nipple pain, cracking, and preventing subacute

Who is the study for?
This trial is for breastfeeding women experiencing nipple pain or cracking, which are early signs of subacute lactation mastitis. The study aims to help these women by testing two different treatments.Check my eligibility
What is being tested?
The effectiveness of extra-virgin coconut oil versus Highly Purified Anhydrous (HPA) Lanolin in preventing and reducing symptoms like nipple pain and cracking, potentially stopping subacute lactation mastitis from developing.See study design
What are the potential side effects?
While the side effects are not explicitly listed, both extra-virgin coconut oil and HPA Lanolin are generally considered safe for topical use with minimal risk of skin irritation or allergic reactions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~six weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and six weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Measurement of Development of Nipple Crack (Nipple Tenderness Scale Storr 1988)
Measurement of change in pain level (Numeric Pain Rating Scale McCaffery, 1989)

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Clinical DataExperimental Treatment1 Intervention
50%Administration of Extra-Virgin Coconut Oil/ 50% HPA Lanolin
Group II: Pre-ScreeningActive Control1 Intervention
Pre-Screening to meet qualifications and conditions of study.
Group III: Demographic Data Stage IActive Control1 Intervention
Data information gathered for enrollment
Group IV: Demographic Data StageIIActive Control1 Intervention
Data gathered after delivery

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Texas Woman's UniversityLead Sponsor
86 Previous Clinical Trials
5,780 Total Patients Enrolled
Harris Health System (Houston, Texas)UNKNOWN

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which individuals meet the criteria for participation in this medical study?

"Individuals eligible for enrollment in this study must be women between the ages of 18 and 45 who are experiencing lactation mastitis. The research aims to recruit a total of 100 participants."

Answered by AI

Is the clinical trial open to participants aged below 35 years?

"To be eligible for this research study, individuals must range from 18 to 45 years of age."

Answered by AI

Has the clinical information received clearance from the FDA?

"The safety rating for Clinical Data is 1 out of 3, as this trial falls under Phase 1 with minimal data supporting its safety and effectiveness."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Effectiveness of Highly Purified Anhydrous (HPA) Lanolin Versus Extra-Virgin Coconut Oil in Preventing Subacute Lactation Mastitis
Sonia Riley 2023. "Effectiveness of Highly Purified Anhydrous (HPA) Lanolin Versus Extra-Virgin Coconut Oil in Preventing Subacute Lactation Mastitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06317688.
~33 spots leftby Aug 2024
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