NCT01846325 is a Phase 2/Phase 3 clinical trial of vitamin E in Asthenozoospermia, sponsored by National Nutrition and Food Technology Institute.

Who is sponsoring NCT01846325?

NCT01846325 is sponsored by National Nutrition and Food Technology Institute.

What drugs are being tested in NCT01846325?

Interventions in NCT01846325: vitamin E, DHA, placebo.

What condition does NCT01846325 study?

NCT01846325 studies Asthenozoospermia.

Is NCT01846325 still recruiting?

NCT01846325 is currently completed. Last updated 14 June 2015.

Last reviewed 2015-06-14 · How we verify

NCT01846325

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

The Effects of Administration of Combined Docosahexaenoic Acid and Vitamin E Supplements on Spermatogram and Seminal Plasma Oxidative Stress in Infertile Men With Asthenozoospermia

Completed Phase 2/Phase 3 Last updated 14 June 2015

What this trial tests

Phase 2/Phase 3 trial testing vitamin E in Asthenozoospermia in 180 participants. Completed in 1 May 2015.

Timeline

1 December 2013

Primary endpoint
1 February 2015

1 May 2015

Quick facts

Lead sponsor	National Nutrition and Food Technology Institute
Phase	Phase 2/Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	180
Start date	1 December 2013
Primary completion	1 February 2015
Estimated completion	1 May 2015

Drugs / interventions tested

vitamin E (VITAMIN E) — full drug profile →
DHA — full drug profile →
placebo

Conditions studied

Asthenozoospermia — all drugs for Asthenozoospermia →

Sponsor

National Nutrition and Food Technology Institute

Who can join

Adults 20 to 45, male only, with Asthenozoospermia. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

sperm motility
Time frame: 12 weeks
spermatogram

Sponsor's own description

Since docosahexaenoic acid (DHA) level in sperm membrane has been shown to be decreased in asthenozoospermic men, the investigators hypothesized that DHA supplementation may improve it. Furthermore, the investigators added vitamin E to it to protect its unsaturated bonds which are susceptible to oxidation and production of free oxygen radicals.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Antioxidants for male subfertility.
Smits RM, Mackenzie-Proctor R, Yazdani A, Stankiewicz MT, et al · · 2019 · cited 155× · PMID 30866036 · DOI 10.1002/14651858.cd007411.pub4
Antioxidants for male subfertility.
de Ligny W, Smits RM, Mackenzie-Proctor R, Jordan V, et al · · 2022 · cited 65× · PMID 35506389 · DOI 10.1002/14651858.cd007411.pub5
Effects of coadministration of DHA and vitamin E on spermatogram, seminal oxidative stress, and sperm phospholipids in asthenozoospermic men: a randomized controlled trial.
Eslamian G, Amirjannati N, Noori N, Sadeghi MR, et al · · 2020 · cited 24× · PMID 32453396 · DOI 10.1093/ajcn/nqaa124

Verify or expand the search:

Other trials of vitamin E

Trials testing the same drug.

NCT07303803 — A Study of Chiglitazar in Patients With Metabolic Dysfunction-associated Steatohepatitis and Type 2 Diabetes Mellitus · Phase 2 · not yet recruiting
NCT06509581 — Vitamin E Supplementation for Children With Transfusion Dependent Beta Thalassemia on Different Iron Chelation Regimen · NA · completed
NCT03674385 — Efficacy of Vit E in PCOS Resistant to Clomiphene Citrate · Phase 2 · completed
NCT02922491 — Effect of Vitamin E Supplementation in Methylation and microRNAs Profile · NA · completed
NCT00392561 — Bangladesh Vitamin E and Selenium Trial · NA · completed

Other recruiting trials for Asthenozoospermia

Currently open trials in the same condition.

NCT07375238 — Effect of Daily Intake of Gazpacho on Semen Quality and Oxidative Stress · NA · recruiting
NCT07252518 — Effect of Pentoxifylline + CoQ10 vs CoQ10 Alone on Sperm Motility in Subfertile Men With Asthenozoospermia · NA · recruiting
NCT07345455 — Probiotics on Sperm Quality in Male Infertility Patients · NA · recruiting
NCT05628987 — The Association of Gut Microbiota and Spermatogenic Dysfunction · recruiting
NCT05328999 — Fertility and the Microbiome · recruiting

Other National Nutrition and Food Technology Institute trials

Trials by the same sponsor.

NCT06900946 — Evaluation of the Effects of Gluten Free Diet on Clinical Symptoms and Glycemic Index in Type 2 Diabetic Patients With N · NA · enrolling by invitation
NCT06351696 — The Effects of Bromelain Supplement in Patients With Ulcerative Colitis · NA · recruiting
NCT06353633 — The Effect of Exclusion Diet for Crohn's Disease Plus Enteral Nutrition on Children and Adolescents With Crohn's Disease · NA · not yet recruiting
NCT06160830 — The Effects of Synbiotic on Cardiovascular and Bone Metabolism Markers in Transplanted Kidney Patients · NA · unknown
NCT06096558 — The Effects of Melatonin on Cardiovascular and Bone Metabolism Markers in Peritoneal Dialysis Patients · NA · unknown

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01846325 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Nutrition and Food Technology Institute
Last refreshed: 14 June 2015

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01846325.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing