Effectiveness of Highly Purified Anhydrous (HPA) Lanolin Versus Extra-Virgin Coconut Oil in Preventing Subacute Lactation Mastitis

NCT06317688 | Enrolling By Invitation Phase 1

• 1 other identifier: TWU IRB-FY2023-157
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Problem of the Study This study was designed to test the effectiveness of the application of extra-virgin coconut oil versus Highly Purified Anhydrous (HPA) Lanolin in ameliorating nipple pain, cracking and eventually the prevention of subacute lactation mastitis in breastfeeding women. It is theorized that the nipple crack, nipple pain are early warning signs of subacute clinical lactation mastitis. Goal is after application of extra-virgin coconut oil comparative analysis will be done at one week, three weeks, and six weeks. These complications associated with development of subacute mastitis can be addressed early during the first six weeks of lactation.

Conditions

Lactation Mastitis; Breast Feeding; Staphylococcus Aureus Infection

Outcome Measures

Primary Outcomes (2)

• Measurement of change in pain level (Numeric Pain Rating Scale McCaffery, 1989)

  The application should reduce the amount of pain at site

  Six weeks

• Measurement of Development of Nipple Crack (Nipple Tenderness Scale Storr 1988)

  Application should or is hypothesized to reduce the incidence of development of a nipple crack

  Six weeks

Study Arms (4)

Pre-Screening

NO INTERVENTION

Pre-Screening to meet qualifications and conditions of study.

Demographic Data Stage I

NO INTERVENTION

Data information gathered for enrollment

Demographic Data StageII

NO INTERVENTION

Data gathered after delivery

Clinical Data

EXPERIMENTAL

50%Administration of Extra-Virgin Coconut Oil/ 50% HPA Lanolin

Dietary Supplement: Extra-Virgin Coconut Oil

Interventions

Extra-Virgin Coconut Oil DIETARY_SUPPLEMENT

Active ingredients act as a destructor of bacteria, viruses and fungus

Also known as: HPA Lanolin (Attention Control)

Clinical Data

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Given Birth and breastfeeding infant at least 50% of time

You may not qualify if:

• Not breastfeeding

Sponsors & Collaborators

• Texas Woman's University: lead
• Harris Health System (Houston, Texas): collaborator

Study Sites (1)

Harris Health System

Houston, Texas, 77030, United States

Location

Related Publications (15)

• References Abbas, A. A., Assikong, E.B., Akeh, M., Upla, P., Tuluma, T.K. (2017). Antimicrobial activity of coconut oil and its derivative (Lauric Acid) on some selected clinical isolates. International Journal of Medical Science and Clinical Inventions (4)8, 3173-3177. https://Doi:10.18535/ijmsci/v4i8.12.

  RESULT

• As'adi N, Kariman N, Mojab F, Pourhoseingholi MA. The effect of Saqez (Pistacia atlantica) ointment on nipple fissure improvement in breastfeeding women during one-month follow-up. Avicenna J Phytomed. 2017 Nov-Dec;7(6):477-485.

  PMID: 29299430 RESULT

• Barbosa-Cesnik C, Schwartz K, Foxman B. Lactation mastitis. JAMA. 2003 Apr 2;289(13):1609-12. doi: 10.1001/jama.289.13.1609. No abstract available.

  PMID: 12672715 RESULT

• Dayrit CS. Coconut Oil in Health and Disease: Its and Monolaurin's Potential as Cure for HIV/AIDS. XXXVII Cocotech Meeting. Chennai, India. July 25, 2000.

  RESULT

• Hildebrandt, E., & Spangler, A. (1993). The effect of modified lanolin on nipple Pain/Damage during the first ten days of breastfeeding. International Journal of Childbirth Education, 8(3), 15-19. Retrieved from https://search.proquest.com/docview/212864505?accountid=45853.

  RESULT

• Jackson KT, Dennis CL. Lanolin for the treatment of nipple pain in breastfeeding women: a randomized controlled trial. Matern Child Nutr. 2017 Jul;13(3):e12357. doi: 10.1111/mcn.12357. Epub 2016 Aug 1.

  PMID: 27477840 RESULT

• Joshi S, Kaushik V, Gode V, Mhaskar S. Coconut Oil and Immunity: What do we really know about it so far? J Assoc Physicians India. 2020 Jul;68(7):67-72.

  PMID: 32602684 RESULT

• Kim S, Jang JE, Kim J, Lee YI, Lee DW, Song SY, Lee JH. Enhanced barrier functions and anti-inflammatory effect of cultured coconut extract on human skin. Food Chem Toxicol. 2017 Aug;106(Pt A):367-375. doi: 10.1016/j.fct.2017.05.060. Epub 2017 May 28.

  PMID: 28564614 RESULT

• Lavergne NA. Does application of tea bags to sore nipples while breastfeeding provide effective relief? J Obstet Gynecol Neonatal Nurs. 1997 Jan-Feb;26(1):53-8. doi: 10.1111/j.1552-6909.1997.tb01507.x.

  PMID: 9017547 RESULT

• Nevin KG, Rajamohan T. Effect of topical application of virgin coconut oil on skin components and antioxidant status during dermal wound healing in young rats. Skin Pharmacol Physiol. 2010;23(6):290-7. doi: 10.1159/000313516. Epub 2010 Jun 3.

  PMID: 20523108 RESULT

• Niazi A, Yousefzadeh S, Rakhshandeh H, Esmaily H, Askari VR. Promising effects of purslane cream on the breast fissure in lactating women: A clinical trial. Complement Ther Med. 2019 Apr;43:300-305. doi: 10.1016/j.ctim.2019.02.002. Epub 2019 Feb 7.

  PMID: 30935548 RESULT

• Ogbolu DO, Oni AA, Daini OA, Oloko AP. In vitro antimicrobial properties of coconut oil on Candida species in Ibadan, Nigeria. J Med Food. 2007 Jun;10(2):384-7. doi: 10.1089/jmf.2006.1209.

  PMID: 17651080 RESULT

• Verallo-Rowell VM, Dillague KM, Syah-Tjundawan BS. Novel antibacterial and emollient effects of coconut and virgin olive oils in adult atopic dermatitis. Dermatitis. 2008 Nov-Dec;19(6):308-15.

  PMID: 19134433 RESULT

• Watson, J. (2008). The Philosophy and Science of Caring. University Press of Colorado.

  RESULT

• Zarshenas M, Zhao Y, Poorarian S, Binns CW, Scott JA. Incidence and Risk Factors of Mastitis in Shiraz, Iran: Results of a Cohort Study. Breastfeed Med. 2017 Jun;12:290-296. doi: 10.1089/bfm.2016.0153. Epub 2017 Apr 18.

  PMID: 28418698 RESULT

MeSH Terms

Conditions

Breast Feeding; Staphylococcal Infections

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate

Model Details: Randomized Control Trial- Random Assignment-Random Selection

Study Record Dates

• First Submitted: November 8, 2023
• First Posted: March 19, 2024
• Study Start: November 6, 2023
• Primary Completion: August 14, 2024
• Study Completion: August 14, 2024
• Last Updated: March 27, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)