Trial · NCT01857310
Folic Acid and Zinc Supplementation Trial (FAZST)
NCT01857310, Not applicable, Completed, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); results first posted 2020-11-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Folic Acid and Zinc Supplementation Trial (FAZST). Trials, record NCT01857310. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01857310
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Folic Acid and Zinc Supplementation Trial (FAZST)
- NCT number
- NCT01857310
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 2,370 participants, actual
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Conditions
- Pregnancy, Live Birth, Spontaneous Abortion
- Interventions
- 5 mg folic acid and 30 mg elemental zinc, Placebo Comparator: Placebo
- First posted
- 2013-05-20
- Last updated
- 2020-11-19
- Results first posted
- 2020-11-19
Source ClinicalTrials.gov
Registered outcomes38
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Live Birth | At delivery | Based on hospital delivery records |
| Primary | Semen Volume | 6 months | Volume of the ejaculate, mL Assessed utilizing the World Health Organization (WHO) semen analysis procedure 5th edition World Health Organization. WHO laboratory manual for the Examination and processing of human semen. 5th Edition ed. Switzerland: 2010. |
| Primary | Sperm Concentration | 6 months | Number of spermatozoa per unit of volume of semen Assessed utilizing the World Health Organization (WHO) semen analysis procedure 5th edition World Health Organization. WHO laboratory manual for the Examination and processing of human semen. 5th Edition ed. Switzerland: 2010. |
| Primary | Sperm Motility | 6 months | % motile (including percentage of progressive motile sperm and percentage of nonprogressive motile sperm) Assessed utilizing the World Health Organization (WHO) semen analysis procedure 5th edition World Health Organization. WHO laboratory manual for the Examination and processing of human semen. 5th Edition ed. Switzerland: 2010. |
| Primary | Sperm Morphology | 6 months | % normal morphology Assessed utilizing the World Health Organization (WHO) semen analysis procedure 5th edition World Health Organization. WHO laboratory manual for the Examination and processing of human semen. 5th Edition ed. Switzerland: 2010. |
| Primary | DNA Fragmentation Index | 6 months | Comet assay used to measure sperm DNA integrity based on excess DNA strand breaks Assessed utilizing the World Health Organization (WHO) semen analysis procedure 5th edition World Health Organization. WHO laboratory manual for the Examination and processing of human semen. 5th Edition ed. Switzerland: 2010. |
| Primary | Total Motile Sperm Count | 6 months | Calculated as semen volume (mL) \* sperm concentration (10\^6 spermatozoa/mL) \* motility (% motile) |
| Secondary | Human Chorionic Gonadotropin (hCG) Detected Pregnancy (Implantation) | For IVF, 12 days post embryo transfer for day 5 embryo transfers, and 14 days post embryo transfer for day 3 embryo transfers; for couples undergoing OI/IUI, after self-report of positive pregnancy test | A quantitative hCG evaluation in serum \> 5 milli-international units per milliliter (mIU/ml) |
| Secondary | Clinical Intrauterine Pregnancy | approximately 6.5 weeks gestation | Visualized gestational sac in the uterus on ultrasound |
| Secondary | Ectopic Pregnancy | approximately 6.5 weeks gestation | Either visualization of no gestational sac in the uterus with a suspicious mass in the adnexa on ultrasound, an hCG level more than 1500 mIU/ml without visualization of an intrauterine gestational sac on ultrasound, or a slowly rising or plateauing serum hCG level without visualization of an intrauterine gestation on ultrasound. |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 registered outcomesOutcomes38
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Live Birth | At delivery | Complete randomized cohort | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Semen Volume | 6 months | Analyzed overall and by fertility treatment stratum (subgroup) 870 and 903 men in the active and placebo treatment arms, respectively, returned for the 6-month study visit. 76 men in the active arm and 67 men in the placebo arm did not provide semen samples at this visit. | mL | MEAN |
| PRIMARY | Sperm Concentration | 6 months | 870 and 903 men in the active and placebo treatment arms, respectively, returned for the 6-month study visit. 76 men in the active arm and 67 men in the placebo arm did not provide semen samples at this visit. Additionally, one male participant in the placebo arm had insufficient quantity or quality to assess concentration. | 10^6 spermatozoa/mL | MEAN |
| PRIMARY | Sperm Motility | 6 months | 870 and 903 men in the active and placebo treatment arms, respectively, returned for the 6-month study visit. 76 men in the active arm and 67 men in the placebo arm did not provide semen samples at this visit. Additionally, one male participant in the placebo arm had insufficient quantity or quality to assess motility. | % motile | MEAN |
| PRIMARY | Sperm Morphology | 6 months | 870 and 903 men in the active and placebo treatment arms, respectively, returned for the 6-month study visit. 76 men in the active arm and 67 men in the placebo arm did not provide semen samples at this visit. Additionally, 19 men in the active arm and 17 men in the placebo arm had insufficient quantity or quality to assess morphology. | % normal | MEAN |
| PRIMARY | DNA Fragmentation Index | 6 months | 870 and 903 men in the active and placebo treatment arms, respectively, returned for the 6-month study visit. 76 men in the active arm and 67 men in the placebo arm did not provide semen samples at this visit. Additionally, 44 men in the active arm and 55 men in the placebo arm had insufficient quantity or quality to assess DFI. | % breakage | MEAN |
| PRIMARY | Total Motile Sperm Count | 6 months | 870 and 903 men in the active and placebo treatment arms, respectively, returned for the 6-month study visit. 76 men in the active arm and 67 men in the placebo arm did not provide semen samples at this visit. Additionally, 1 man in the active arm and 2 men in the placebo arm had insufficient quantity or quality to assess total motile count. | million motile sperm | MEAN |
| SECONDARY | Human Chorionic Gonadotropin (hCG) Detected Pregnancy (Implantation) | For IVF, 12 days post embryo transfer for day 5 embryo transfers, and 14 days post embryo transfer for day 3 embryo transfers; for couples undergoing OI/IUI, after self-report of positive pregnancy test | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Clinical Intrauterine Pregnancy | approximately 6.5 weeks gestation | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Ectopic Pregnancy | approximately 6.5 weeks gestation | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 outcomesResults by group130
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Live Birth | Folic Acid and Zinc Supplementation | Overall | 404 | Participants | |
| Live Birth | Placebo | Overall | 416 | Participants | |
| Live Birth | Folic Acid and Zinc Supplementation | IVF stratum | 97 | Participants | |
| Live Birth | Placebo | IVF stratum | 91 | Participants | |
| Live Birth | Folic Acid and Zinc Supplementation | Other treatment onsite | 264 | Participants | |
| Live Birth | Placebo | Other treatment onsite | 277 | Participants | |
| Live Birth | Folic Acid and Zinc Supplementation | Other treatment offsite | 43 | Participants | |
| Live Birth | Placebo | Other treatment offsite | 48 | Participants | |
| Semen Volume | Folic Acid and Zinc Supplementation | Overall | 3.5 | Standard Deviation 1.7 | mL |
| Semen Volume | Placebo | Overall | 3.5 | Standard Deviation 1.8 | mL |
1 to 10 of 130Source ClinicalTrials.gov
See all 130 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Primary Analysis: Live Birth | STARTED | Folic Acid and Zinc Supplementation | 1,185 | |
| Primary Analysis: Live Birth | STARTED | Placebo | 1,185 | |
| Primary Analysis: Live Birth | COMPLETED | Folic Acid and Zinc Supplementation | 1,185 | |
| Primary Analysis: Live Birth | COMPLETED | Placebo | 1,185 | |
| Primary Analysis: Live Birth | NOT COMPLETED | Folic Acid and Zinc Supplementation | 0 | |
| Primary Analysis: Live Birth | NOT COMPLETED | Placebo | 0 | |
| Secondary Analysis: Semen Quality at 6m | STARTED | Folic Acid and Zinc Supplementation | 1,185 | |
| Secondary Analysis: Semen Quality at 6m | STARTED | Placebo | 1,185 | |
| Secondary Analysis: Semen Quality at 6m | COMPLETED | Folic Acid and Zinc Supplementation | 870 | |
| Secondary Analysis: Semen Quality at 6m | COMPLETED | Placebo | 903 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events30
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal discomfort or pain | Gastrointestinal disorders | Folic Acid and Zinc Supplementation | 66 | 1,185 | |
| other | Abdominal discomfort or pain | Gastrointestinal disorders | Placebo | 40 | 1,185 | |
| other | Pyrexia | General disorders | Folic Acid and Zinc Supplementation | 66 | 1,185 | |
| other | Pyrexia | General disorders | Placebo | 62 | 1,185 | |
| other | Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Folic Acid and Zinc Supplementation | 57 | 1,185 | |
| other | Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Placebo | 60 | 1,185 | |
| serious | Myocardial infarction | Cardiac disorders | Folic Acid and Zinc Supplementation | 0 | 1,185 | |
| serious | Myocardial infarction | Cardiac disorders | Placebo | 1 | 1,185 | |
| serious | Pericardial effusion | Cardiac disorders | Folic Acid and Zinc Supplementation | 0 | 1,185 | |
| serious | Pericardial effusion | Cardiac disorders | Placebo | 1 | 1,185 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Folic Acid and Zinc Supplementation | 0 | 1,185 |
| Total, all-cause mortality | Placebo | 0 | 1,185 |
| Total, other adverse events | Folic Acid and Zinc Supplementation | 189 | 1,185 |
| Total, other adverse events | Placebo | 162 | 1,185 |
| Total, serious adverse events | Folic Acid and Zinc Supplementation | 7 | 1,185 |
| Total, serious adverse events | Placebo | 5 | 1,185 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons16
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Folic Acid and Zinc Supplementation vs Placebo: Preeclampsia or Gestational Hypertension | Trial comparisons |
| Folic Acid and Zinc Supplementation vs Placebo: Early Pregnancy Loss | Trial comparisons |
| Folic Acid and Zinc Supplementation vs Placebo: Human Chorionic Gonadotropin (hCG) Detected Pregnancy (Implantation) | Trial comparisons |
| Folic Acid and Zinc Supplementation vs Placebo: Neonatal Mortality | Trial comparisons |
| Folic Acid and Zinc Supplementation vs Placebo: Gestational Diabetes | Trial comparisons |
| Folic Acid and Zinc Supplementation vs Placebo: Small for Gestational Age | Trial comparisons |
| Folic Acid and Zinc Supplementation vs Placebo: Preterm Delivery | Trial comparisons |
| Folic Acid and Zinc Supplementation vs Placebo: Severe Maternal Morbidity | Trial comparisons |
| Folic Acid and Zinc Supplementation vs Placebo: Ectopic Pregnancy | Trial comparisons |
| Folic Acid and Zinc Supplementation vs Placebo: Stillbirth | Trial comparisons |
1 to 10 of 16
See all 16 trial comparisonsTests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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