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Effect of Fenugreek on Milk Production (fenugreek)

This study has been terminated.
(Low enrollment; investigator chose not to continue study)
Sponsor:
Information provided by (Responsible Party):
Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier:
NCT00851591
First received: February 24, 2009
Last updated: June 30, 2014
Last verified: June 2014

February 24, 2009
June 30, 2014
September 2008
August 2012   (final data collection date for primary outcome measure)
The Main Outcome Variable of This Study is the Quantity of Milk Produced. [ Time Frame: "Day 0" , "Day 8" ] [ Designated as safety issue: No ]
The single value was calculated average from day 0 and day 8.
The main outcome variable of this study will be the quantity of milk produced. [ Time Frame: day 0; day 8 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00851591 on ClinicalTrials.gov Archive Site
Secondary Outcome Variables Are to Include Milk-fat Content and Protein Content. [ Time Frame: day 0; day 8 ] [ Designated as safety issue: No ]
Secondary outcome variables will include milk-fat content and protein content. [ Time Frame: day 0; day 8 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Effect of Fenugreek on Milk Production
Effect of Fenugreek on Milk Production

Each year, approximately 3 million mothers in the USA alone leave the hospital breastfeeding an infant. However, a large number discontinue breastfeeding, because milk synthesis is poor or simply stops. Termed "Insufficient Milk Syndrome," this condition probably accounts for approximately 5-10% of the total population of breastfeeding mothers and includes many mothers with premature infants, mothers with polycystic ovary syndrome, and a myriad of other unknown causes. The mother's inability to breastfeed causes enormous feelings of inadequacy, grief, depression, and other problems, not to mention increased health risks to the infant.

The most popular herbal remedy used around the world for increasing milk synthesis is fenugreek. Fenugreek (Trigonella foenum graecum) is a seed product from the legume family that is commonly sold, since the dried, ripe seed and extracts are used as an artificial flavor for maple syrup. When used orally in amounts commonly found in foods, it has been granted Generally Recognized as Safe (GRAS) status in the USA by the FDA. Although it is used by millions of women around the world to increase their milk supply, we have only one small case report which suggested it might actually increase the milk supply.

In this one study, the authors found an approximate 40% increase in milk production, although the study was not blinded, nor did they use a control population. For these reasons, we still do not know with certainty if fenugreek works as a galactagogue.

This study is designed to accurately determine if seven days of fenugreek will stimulate milk production in a selected group of subjects with poor milk supply. We hypothesize that the women enrolled in the test group will have increased milk production at the end of the 8-day study.

This study is designed to accurately determine if seven days of fenugreek will stimulate milk production in a selected group of subjects with poor milk supply. We hypothesize that the women enrolled in the test group will have increased milk production at the end of the 8-day study.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Lactation
  • Drug: fenugreek
    3 capsules 3 times per day with a full glass of water each dose for 7 days
    Other Name: Trigonella foenum-graecum, Alhova, Bird's Foot, Greek Clover
  • Drug: Placebo (Psyllium)
    3 capsules 3 times a day with a full glass of water each dose for 7 days
    Other Names:
    • Metamucil®,
    • Hydrocil Instant®,
    • Modane Bulk Powder®
  • Experimental: Fenugreek category 1
    receive fenugreek
    Intervention: Drug: fenugreek
  • Placebo Comparator: Placebo Category 2
    receive placebo
    Intervention: Drug: Placebo (Psyllium)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
3
August 2012
August 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Mothers 2-12 weeks postpartum
  • Mothers with term infants 37 weeks gestation or older
  • Mothers with poor milk supply documented by professional lactation consultants
  • Mothers whose milk supply is less than 600 cc per 24 hours
  • Mothers who agree not to breastfeed or provide their milk to their infants during this study

Exclusion Criteria:

  • Mothers with documented mastitis
  • Mothers with breast engorgement
  • Mothers with inverted nipples
  • Maternal BMI greater than 35
  • Mothers currently consuming Reglan, Domperidone or other drugs/herbals used to induce milk production
  • Mothers who are clinically ill or hospitalized, or taking the following medications:

    1. Diuretics
    2. Pseudoephedrine
    3. Anticholinergics
    4. Warfarin or any anticoagulant
    5. An estrogen-containing birth control pill
  • Mothers with Diabetes mellitus
  • Mothers who have had breast surgery that could alter milk synthesis or production
  • Mothers diagnosed with Polycystic ovary syndrome
  • Mothers with tubular breasts or breasts with insufficient glandular tissue
  • Mothers diagnosed with Asthma or atopic disease
  • Mothers who are known to be allergic to peanuts or soybeans
  • Mothers who are pregnant
  • Mothers whose milk supply per 24 hours exceeds 600 mL
  • Mothers with Obstetrical evaluation recommending exclusion
Female
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00851591
A08-3479
Yes
Texas Tech University Health Sciences Center
Texas Tech University Health Sciences Center
Not Provided
Study Director: Thomas W Hale, PhD Texas Tech University Health Sciences Center
Texas Tech University Health Sciences Center
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP