Nutrient DeficiencyMFSNCT05166980
Study of Multiply-fortified Salt Among Women of Reproductive Age and Preschool Children in India
A study testing Mutiply-fortified salt and Iodized salt in people with Nutrient Deficiency, run by University of California, San Francisco at 1 site in India.
Trial summary
Micronutrient (MN) deficiencies are highly prevalent in India, particularly among women of reproductive age (WRA) and preschool aged children (PSC). MN fortification of a staple food or condiment can be an effective strategy for improving the MN status of nutritionally vulnerable populations, as the approach is… Read more about this study
- Who is it for?
- Ages 12 months to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrient Deficiency
- What is being tested?
- Mutiply-fortified salt and Iodized salt
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,389 participants
- Where
- 1 siteIndia
- Study dates
- 17 Oct 2022to 2 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 months to 49 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 18-49 years of age;
- Not currently pregnant (self-reported);
- Not severely anemia (defined as a hemoglobin concentration < 8 g/dL);
- Not planning to become pregnant within the next year;
- Permanent resident of the study village with no plans to move or travel outside the village for more than 4 weeks over the next 12 months;
- No serious health problems that requires regular visits to a health facility;
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- Willingness to use refined salt provided by the study as a primary source of household discretionary salt.
- Child 12-59 months of age at the time of enrollment;
- Child's mother or primary female caregiver has been enrolled into the parent trial;
- Not severely anemic (defined as a hemoglobin concentration < 7 g/dL);
- Child's family is a permanent resident of the study village with no plans to move or travel outside the village for more than 4 weeks over the next 12 months;
- No serious medical problems that interfere with the child's eating practices;
- Child's mother or primary female caregiver is willing to use refined salt provided by the study as the primary source of the household's discretionary salt for the course of the study.
Who cannot join
- Age <18 or > 49 years of age;
- Pregnant at the time of enrollment (self report) or planning to become pregnant within the next year;
- Severely anemic (i.e. hemoglobin concentration < 8 g/dL);
- Not a permanent resident of the study area;
- Planning to leave the study area for at least one month over the study period;
- Serious health problem that interferes with eating practices and/or requires hospitalization;
Show all 13Show fewer
- Unwilling to use refined salt provided by the study as the primary source of the household's discretionary salt.
- Child age < 12 or > 59 months of age;
- Child's mother has not been enrolled in the parent trial;
- Severely anemic (i.e. hemoglobin concentration < 7 g/dL);
- Child's family is not a permanent resident of the study village and/or has plans to travel outside the village for more than 4 weeks over the next 12 months;
- Serious health problem that interferes with the child's eating practices;
- Child's mother or primary female caregiver is unwilling to use refined salt provided by the study as the primary sources of the household's discretionary salt for the course of the study.
Trial locations and contacts
1 site in 1 country.
India1 site
Postgraduate Institute of Medical Education and Research, Chandigarh
Chandigarh
About this study
Micronutrient (MN) deficiencies are highly prevalent in India, particularly among women of reproductive age (WRA) and preschool aged children (PSC). MN fortification of a staple food or condiment can be an effective strategy for improving the MN status of nutritionally vulnerable populations, as the approach is cost-effective, utilizes existing delivery systems, can deliver multiple MNs simultaneously, and does not require behavior change by the population. Salt is a particularly attractive vehicle for multiple MN fortification in India, as it is universally consumed in fairly consistent amounts; and 93% of households already use adequately iodized salt.
The overall goal of this study is to evaluate the nutritional impact of quintuply-fortified salt with iron in the form of FePP (FePP-Q5S, i.e. salt fortified with iron in the form of ferric pyrophosphate plus ethylenediaminetetraacetic acid as an enhancer of absorption; zinc in the form of zinc oxide; vitamin B12; folic acid; and iodine) vs. quintuply-fortified salt with iron in the form of eFF (eFF-Q5S i.e. salt fortified with iron in the form of encapsulated ferrous fumarate; zinc in the form of zinc oxide, vitamin B12, folic acid, and iodine) vs. iodized salt (IS) for the improvement of micronutrient status among nonpregnant WRA and preschool-aged children (12-59 months of age) in Punjab, India.
Enrolled women (and their affiliated households) will be randomized to receive 1 kg of their assigned study salt per month for 12 months, and will be instructed to use the study salt in place of their usual salt. Blood and urine samples will be collected from participant WRA and PSC at enrollment, 6 months and at the end of the 12-month intervention period. The change in the mean concentration of various MN biomarkers will be considered primary outcomes. Stool samples will also be collected from a subgroup of women and children to assess changes in the gut microbiome over the intervention period.
- Conditions
- Nutrient Deficiency
- Being tested
- Mutiply-fortified salt, Iodized salt
- Keywords
- Micronutrient deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mutiply-fortified saltDietary supplement
Also called Quintuply-fortified salt
Salt fortified with iron, zinc, vitamin B12, folic acid, and iodine
Iodized saltDietary supplement
Also called Salt fortified with iodine
Salt fortified with iodine
| Study group | Role | What they receive |
|---|---|---|
| FePP-Q5S | Experimental | Salt fortified with iron in the form of ferric pyrophosphate (at 1.3 mg of iron per gram of salt) plus ethylenediaminetetraacetic acid (EDTA) as an enhancer of absorption, zinc in the form of zinc oxide (at 1.4 mg of zinc per gram of salt), vitamin B12 (at 0.6 ug of vitamin B12 per gram of salt), folic acid (at 52 ug per gram of salt) and iodine (at 30 mg of iodine per gram of salt). Mean intake of discretionary salt among women of reproductive age in the study area is 4.6 grams per day. Therefore, the FePP-Q5S will deliver an average of 6.0 mg of iron, 6.4 mg of zinc, 2.8 ug of vitamin B12, 241 ug of folic acid, and 138 mg of iodine to each participating woman per day. Receives: Dietary Supplement: Mutiply-fortified salt |
| eFF-Q5S | Experimental | Salt fortified with iron in the form of encapsulated ferrous fumarate (at 1.3 mg of iron per gram of salt), zinc in the form of zinc oxide (at 1.4 mg of zinc per gram of salt), vitamin B12 (at 0.6 ug of vitamin B12 per gram of salt), folic acid (at 52 ug per gram of salt) and iodine (at 30 mg of iodine per gram of salt). Mean intake of discretionary salt among women of reproductive age in the study area is 4.6 grams per day. Therefore, the eFF-Q5S will deliver an average of 6.0 mg of iron, 6.4 mg of zinc, 2.8 ug of vitamin B12, 241 ug of folic acid, and 138 mg of iodine to each participating woman per day. Receives: Dietary Supplement: Mutiply-fortified salt |
| Iodized Salt | Active comparator | Iodized salt containing 30 mg of iodine per gram of salt. Mean intake of discretionary salt among women of reproductive age in the study area is 4.6 grams per day. Therefore, the iodized salt will deliver an average of 138 mg of iodine to each participating woman per day. Receives: Dietary Supplement: Iodized salt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum ferritin
Change in inflammation-adjusted mean serum ferritin concentration
Measured: Enrollment to 12 months (i.e. end of intervention period)
Change in hemoglobin
Change in mean hemoglobin concentration
Measured: Enrollment to 12 months (i.e. end of intervention period)
Change in soluble transferrin
Change in inflammation-adjusted mean soluble transferrin concentration
Measured: Enrollment to 12 months (i.e. end of intervention period)
Change in red blood cell folate
Change in mean red blood cell folate concentration
Measured: Enrollment to 12 months (i.e. end of intervention period)
Change in plasma zinc
Change in mean plasma zinc concentration
Measured: Enrollment to 12 months (i.e. end of intervention period)
Change in serum vitamin B12
Change in mean serum vitamin B12 concentration
Measured: Enrollment to 12 months (i.e. end of intervention period)
Change in holo-transcobalamin
Change in mean holo-transcobalamin concentration
Measured: Enrollment to 12 months (i.e. end of intervention period)
Change in methylmalonic acid
Change in mean concentration of methylmalonic acid
Measured: Enrollment to 12 months (i.e. end of intervention period)
Change in serum folate
Change in mean serum folate concentration
Measured: Enrollment to 12 months (i.e. end of intervention period)
Change in urinary iodine
Change in mean urinary iodine concentration
Measured: Enrollment to 12 months (i.e. end of intervention period)
Change in serum thyroglobulin
Change in mean serum thyroglobulin concentration
Measured: Enrollment to 12 months (i.e. end of intervention period)
Secondary outcomes (2)
Change in nail zinc
Change in mean fingernail zinc concentration
Measured: Enrollment to 12 months (i.e. end of intervention period)
Change in gut microbiota
Change in the abundance of potentially beneficial microbiota in the gut
Measured: Enrollment to 12 months (i.e. end of intervention period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start17 Oct 2022
- Primary completion2 May 2024
- Study completion2 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Nutrient DeficiencyStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3-armed, double-blind, community-based efficacy trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,389 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Post Graduate Institute of Medical Education and Research, Chandigarh, University of California, Davis, University of Colorado, Denver
- Responsible party
- Sponsor
- Investigators
- Christine McDonald, ScD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05166980
- Sponsor's protocol ID
- MFS_1.2
- Acronym
- MFS
- Status last verified
- May 2024
- First submitted
- 20 Dec 2021
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: As soon as the manuscripts summarizing the study's primary outcomes are published, all datasets will be posted to Open Science Framework and made available to the public in accordance with the Gates Foundation's Open Data Policy.
Publications
Thompson L, Goh YE, Jamwal M, Singh BL, Brar GK, Arnold CD, Westcott J, Long JM, Krebs NF, Zivkovic A, Das R, Duggal M, McDonald CM. The Effect of Quintuply-Fortified Salt on the Gut Microbiome of Young Children 1-5 y of Age in Punjab, India; A Substudy of a Randomized, Community-Based Trial. Curr Dev Nutr. 2025 Oct 23;9(11):107580. doi: 10.1016/j.cdnut.2025.107580. eCollection 2025 Nov.
PubMed 41323692Goh YE, Duggal M, Das R, Manger MS, Jamwal M, Singh BL, Brar GK, Long JM, Westcott J, Thompson L, Arnold CD, Krebs NF, Brown KH, McDonald CM. Effects of quintuply-fortified salt on the micronutrient status of females of reproductive age in Punjab, India: a randomized, community-based trial. Am J Clin Nutr. 2025 Jul;122(1):146-156. doi: 10.1016/j.ajcnut.2025.04.009. Epub 2025 Jun 6.
PubMed 40610127Thompson L, Goh YE, Jamwal M, Singh BL, Brar GK, Arnold CD, Westcott J, Krebs NF, Zivkovic A, Das R, Duggal M, McDonald CM. The Effect of Quintuply-Fortified Salt on the Gut Microbiome of Nonpregnant Women of Reproductive Age in Punjab, India: A Substudy of a Randomized, Community-Based Trial. J Nutr. 2025 Jun;155(6):1899-1908. doi: 10.1016/j.tjnut.2025.04.012. Epub 2025 Apr 15.
PubMed 40246238McDonald CM, Brown KH, Goh YE, Manger MS, Arnold CD, Krebs NF, Westcott J, Long JM, Gibson RS, Jamwal M, Singh BL, Dahiya N, Budhija D, Das R, Duggal M. Quintuply-fortified salt for the improvement of micronutrient status among women of reproductive age and preschool-aged children in Punjab, India: protocol for a randomized, controlled, community-based trial. BMC Nutr. 2022 Sep 6;8(1):98. doi: 10.1186/s40795-022-00583-y.
PubMed 36068647
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Multiply-fortified Salt Among Women of Reproductive Age and Preschool Children in India
- ClinicalTrials.gov ID
- NCT05166980
- Acronym / sponsor ID
- MFS / MFS_1.2
- Conditions
- Nutrient Deficiency
- Keywords
- Micronutrient deficiencies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,389 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Post Graduate Institute of Medical Education and Research, Chandigarh, University of California, Davis, University of Colorado, Denver
- Study start
- 17 Oct 2022 (actual)
- Primary completion
- 2 May 2024 (actual)
- Study completion
- 2 May 2024 (actual)
- First posted
- 22 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Micronutrient (MN) deficiencies are highly prevalent in India, particularly among women of reproductive age (WRA) and preschool aged children (PSC). MN fortification of a staple food or condiment can be an effective strategy for improving the MN status of nutritionally vulnerable populations, as the approach is cost-effective, utilizes existing delivery systems, can deliver multiple MNs simultaneously, and does not require behavior change by the population. Salt is a particularly attractive vehicle for multiple MN fortification in India, as it is universally consumed in fairly consistent amounts; and 93% of households already use adequately iodized salt.
The overall goal of this study is to evaluate the nutritional impact of quintuply-fortified salt with iron in the form of FePP (FePP-Q5S, i.e. salt fortified with iron in the form of ferric pyrophosphate plus ethylenediaminetetraacetic acid as an enhancer of absorption; zinc in the form of zinc oxide; vitamin B12; folic acid; and iodine) vs. quintuply-fortified salt with iron in the form of eFF (eFF-Q5S i.e. salt fortified with iron in the form of encapsulated ferrous fumarate; zinc in the form of zinc oxide, vitamin B12, folic acid, and iodine) vs. iodized salt (IS) for the improvement of micronutrient status among nonpregnant WRA and preschool-aged children (12-59 months of age) in Punjab, India.
Enrolled women (and their affiliated households) will be randomized to receive 1 kg of their assigned study salt per month for 12 months, and will be instructed to use the study salt in place of their usual salt. Blood and urine samples will be collected from participant WRA and PSC at enrollment, 6 months and at the end of the 12-month intervention period. The change in the mean concentration of various MN biomarkers will be considered primary outcomes. Stool samples will also be collected from a subgroup of women and children to assess changes in the gut microbiome over the intervention period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 3-armed, double-blind, community-based efficacy trial
| Arm | Type | Receives |
|---|---|---|
| FePP-Q5S | Experimental | Dietary Supplement: Mutiply-fortified saltSalt fortified with iron in the form of ferric pyrophosphate (at 1.3 mg of iron per gram of salt) plus ethylenediaminetetraacetic acid (EDTA) as an enhancer of absorption, zinc in the form of zinc oxide (at 1.4 mg of zinc per gram of salt), vitamin B12 (at 0.6 ug of vitamin B12 per gram of salt), folic acid (at 52 ug per gram of salt) and iodine (at 30 mg of iodine per gram of salt). Mean intake of discretionary salt among women of reproductive age in the study area is 4.6 grams per day. Therefore, the FePP-Q5S will deliver an average of 6.0 mg of iron, 6.4 mg of zinc, 2.8 ug of vitamin B12, 241 ug of folic acid, and 138 mg of iodine to each participating woman per day. |
| eFF-Q5S | Experimental | Dietary Supplement: Mutiply-fortified saltSalt fortified with iron in the form of encapsulated ferrous fumarate (at 1.3 mg of iron per gram of salt), zinc in the form of zinc oxide (at 1.4 mg of zinc per gram of salt), vitamin B12 (at 0.6 ug of vitamin B12 per gram of salt), folic acid (at 52 ug per gram of salt) and iodine (at 30 mg of iodine per gram of salt). Mean intake of discretionary salt among women of reproductive age in the study area is 4.6 grams per day. Therefore, the eFF-Q5S will deliver an average of 6.0 mg of iron, 6.4 mg of zinc, 2.8 ug of vitamin B12, 241 ug of folic acid, and 138 mg of iodine to each participating woman per day. |
| Iodized Salt | Active comparator | Dietary Supplement: Iodized saltIodized salt containing 30 mg of iodine per gram of salt. Mean intake of discretionary salt among women of reproductive age in the study area is 4.6 grams per day. Therefore, the iodized salt will deliver an average of 138 mg of iodine to each participating woman per day. |
Who may qualify
- Ages
- 12 months to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (13 listed)
- 18-49 years of age;
- Not currently pregnant (self-reported);
- Not severely anemia (defined as a hemoglobin concentration < 8 g/dL);
- Not planning to become pregnant within the next year;
- Permanent resident of the study village with no plans to move or travel outside the village for more than 4 weeks over the next 12 months;
Key exclusion criteria (13 listed)
- Age <18 or > 49 years of age;
- Pregnant at the time of enrollment (self report) or planning to become pregnant within the next year;
- Severely anemic (i.e. hemoglobin concentration < 8 g/dL);
- Not a permanent resident of the study area;
- Planning to leave the study area for at least one month over the study period;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mutiply-fortified saltAlso: Quintuply-fortified saltSalt fortified with iron, zinc, vitamin B12, folic acid, and iodine | Dietary supplement | FePP-Q5S, eFF-Q5S |
| Iodized saltAlso: Salt fortified with iodineSalt fortified with iodine | Dietary supplement | Iodized Salt |
Primary outcome
Change in serum ferritin
Time frame: Enrollment to 12 months (i.e. end of intervention period)
Change in inflammation-adjusted mean serum ferritin concentration
Change in hemoglobin
Time frame: Enrollment to 12 months (i.e. end of intervention period)
Change in mean hemoglobin concentration
Change in soluble transferrin
Time frame: Enrollment to 12 months (i.e. end of intervention period)
Change in inflammation-adjusted mean soluble transferrin concentration
Change in red blood cell folate
Time frame: Enrollment to 12 months (i.e. end of intervention period)
Change in mean red blood cell folate concentration
Change in plasma zinc
Time frame: Enrollment to 12 months (i.e. end of intervention period)
Change in mean plasma zinc concentration
Change in serum vitamin B12
Time frame: Enrollment to 12 months (i.e. end of intervention period)
Change in mean serum vitamin B12 concentration
Change in holo-transcobalamin
Time frame: Enrollment to 12 months (i.e. end of intervention period)
Change in mean holo-transcobalamin concentration
Change in methylmalonic acid
Time frame: Enrollment to 12 months (i.e. end of intervention period)
Change in mean concentration of methylmalonic acid
Change in serum folate
Time frame: Enrollment to 12 months (i.e. end of intervention period)
Change in mean serum folate concentration
Change in urinary iodine
Time frame: Enrollment to 12 months (i.e. end of intervention period)
Change in mean urinary iodine concentration
Change in serum thyroglobulin
Time frame: Enrollment to 12 months (i.e. end of intervention period)
Change in mean serum thyroglobulin concentration
2 secondary outcomes
Change in nail zinc
Time frame: Enrollment to 12 months (i.e. end of intervention period)
Change in gut microbiota
Time frame: Enrollment to 12 months (i.e. end of intervention period)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Derived from this study: PubMed 41323692Thompson L, Goh YE, Jamwal M, Singh BL, Brar GK, Arnold CD, Westcott J, Long JM, Krebs NF, Zivkovic A, Das R, Duggal M, McDonald CM. The Effect of Quintuply-Fortified Salt on the Gut Microbiome of Young Children 1-5 y of Age in Punjab, India; A Substudy of a Randomized, Community-Based Trial. Curr Dev Nutr. 2025 Oct 23;9(11):107580. doi: 10.1016/j.cdnut.2025.107580. eCollection 2025 Nov.
- Derived from this study: PubMed 40610127Goh YE, Duggal M, Das R, Manger MS, Jamwal M, Singh BL, Brar GK, Long JM, Westcott J, Thompson L, Arnold CD, Krebs NF, Brown KH, McDonald CM. Effects of quintuply-fortified salt on the micronutrient status of females of reproductive age in Punjab, India: a randomized, community-based trial. Am J Clin Nutr. 2025 Jul;122(1):146-156. doi: 10.1016/j.ajcnut.2025.04.009. Epub 2025 Jun 6.
- Derived from this study: PubMed 40246238Thompson L, Goh YE, Jamwal M, Singh BL, Brar GK, Arnold CD, Westcott J, Krebs NF, Zivkovic A, Das R, Duggal M, McDonald CM. The Effect of Quintuply-Fortified Salt on the Gut Microbiome of Nonpregnant Women of Reproductive Age in Punjab, India: A Substudy of a Randomized, Community-Based Trial. J Nutr. 2025 Jun;155(6):1899-1908. doi: 10.1016/j.tjnut.2025.04.012. Epub 2025 Apr 15.
- Derived from this study: PubMed 36068647McDonald CM, Brown KH, Goh YE, Manger MS, Arnold CD, Krebs NF, Westcott J, Long JM, Gibson RS, Jamwal M, Singh BL, Dahiya N, Budhija D, Das R, Duggal M. Quintuply-fortified salt for the improvement of micronutrient status among women of reproductive age and preschool-aged children in Punjab, India: protocol for a randomized, controlled, community-based trial. BMC Nutr. 2022 Sep 6;8(1):98. doi: 10.1186/s40795-022-00583-y.
- Individual participant dataSharing planned: Yes. As soon as the manuscripts summarizing the study's primary outcomes are published, all datasets will be posted to Open Science Framework and made available to the public in accordance with the Gates Foundation's Open Data Policy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine McDonald, ScD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mutiply-fortified salt and Iodized salt in people with Nutrient Deficiency, run by University of California, San Francisco at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum ferritin (time frame: Enrollment to 12 months (i.e. end of intervention period)). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05166980, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2024.