NCT02122211

Brief Summary

The ability of sperm to swim is important for normal fertility. Men with a genetic variation in the gene coding for Choline Dehydrogenase (CHDH) have decreased energy production by sperm, and their sperm do not swim normally. The metabolic product of this gene is a nutrient called betaine (found normally in the diet as a part of many foods such as spinach, beets and grain products). This study tests whether treatment with betaine is safe and whether it can normalize energy production in sperm of these men and restore normal swimming ability.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2014

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

April 17, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 24, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

September 8, 2016

Status Verified

September 1, 2016

Enrollment Period

2.3 years

First QC Date

April 17, 2014

Last Update Submit

September 7, 2016

Conditions

Men Carrying 2 Minor Alleles for Choline Dehydrogenase rs12676Male Infertility

Keywords

Sperm motility

Outcome Measures

Primary Outcomes (6)

  • Change in sperm motility from baseline

    Assessed using Computer-Aided Sperm Analysis methodology

    On day zero, day 10, day 30, day 50 and at the end of the 75 day treatment period

  • Change in sperm count from baseline

    On day zero, day 10, day 30, day 50 and at the end of the 75 day treatment period

  • Change in sperm mitochondrial function from baseline

    Using Seahorse biochemical function assessment

    On day zero, day 10, day 30, day 50 and at the end of the 75 day treatment period

  • Change in sperm ultrastructure from baseline

    Using light and transmission electron microscopy

    On day zero, day 10, day 30, day 50 and at the end of the 75 day treatment period

  • Change in sperm choline dehydrogenase concentration from baseline

    Assessed by Western Blot analysis

    On day zero, day 10, day 30, day 50 and at the end of the 75 day treatment period

  • Change in sperm betaine concentration from baseline

    On day zero, day 10, day 30, day 50 and at the end of the 75 day treatment period

Secondary Outcomes (10)

  • Betaine intake

    At screening and every 21 days during the study

  • Change in complete blood count from baseline

    At 0, 10, 30, 50, and 75 days on treatment

  • Change in uric acid concentration from baseline

    At 0, 10, 30, 50, and 75 days on treatment

  • Change in alkaline phosphatase concentration from baseline

    At 0, 10, 30, 50, and 75 days on treatment

  • Change in aspartate transaminase concentration from baseline

    At 0,10, 30, 50, and 75 days on treatment

  • +5 more secondary outcomes

Study Arms (1)

Betaine supplement

EXPERIMENTAL

Will use powdered betaine (BetaPower, Dupont Nutrition) that is commercially available for food uses. This powder will be delivered as capsules containing 0.5 gram of powdered betaine which will be administered as eleven capsules twice per day (6 in the morning, 5 in the evening) for a daily total of 6 grams of betaine.

Drug: Betaine supplement

Interventions

Betaine supplementDRUG
Also known as: BetaPower (Dupont Nutrition)
Betaine supplement

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • year old men of multiple races and ethnicities
  • Estimated dietary intake of betaine of \<150 mg/day
  • Carrying two alleles of the rs 12676 single nucleotide polymorphism

You may not qualify if:

  • Cystathionine-beta-synthase (CBS) deficiency
  • Currently taking betaine supplements
  • Currently receiving chemotherapy, radiation or any gonadotoxic drug
  • Female gender

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNC Nutrition Research Institute

Kannapolis, North Carolina, 28081, United States

Location

Related Publications (1)

  • Johnson AR, Lao S, Wang T, Galanko JA, Zeisel SH. Choline dehydrogenase polymorphism rs12676 is a functional variation and is associated with changes in human sperm cell function. PLoS One. 2012;7(4):e36047. doi: 10.1371/journal.pone.0036047. Epub 2012 Apr 27.

    PMID: 22558321BACKGROUND

MeSH Terms

Conditions

Infertility, Male

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Study Officials

  • Steven Zeisel, MD, PhD

    University of North Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2014

First Posted

April 24, 2014

Study Start

April 1, 2014

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

September 8, 2016

Record last verified: 2016-09

Locations

US(1)