AdolescentsPhase 3NCT03287882
Effect of Micronutrients and Life Skills Education on the Health and Nutrition of Adolescent and Young Women in Pakistan
A Phase 3 study testing Multiple micronutrients (UNIMMAP composition) and Life skills based education in people with Adolescents and Anemia, run by Aga Khan University at 1 site in Pakistan.
Trial summary
The primary aims of this study are: 1) To evaluate the impact of supplementation with multiple micronutrients (MMN) from preconception and life skills education among women 15-18.9 years of age at enrolment on the prevalence of anemia in a population setting; and 2) To evaluate the impact of supplementation with MMN… Read more about this study
- Who is it for?
- Ages 15 to 24 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Adolescents, Anemia, Pregnancy
- What is being tested?
- Multiple micronutrients (UNIMMAP composition) and Life skills based education
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25,447 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Jun 2017to Feb 2022
- Phase
- Phase 3
- 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 15 to 24 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Minimum age at enrolment: 15 years
- Maximum age at enrolment: 23 years
- Any marital status
- Intend to comply with study intervention and follow up
Who cannot join
- Women participating in other nutrition trials
- Women who intend to leave the study area
- Women who are already pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Cluster Randomized Effectiveness Trial of Multiple Micronutrient Supplementation and Life Skills Education Provided From Preconception on Health and Nutrition Outcomes of Young, Reproductive-age Pakistani Women (15-24 Years)
The primary aims of this study are: 1) To evaluate the impact of supplementation with multiple micronutrients (MMN) from preconception and life skills education among women 15-18.9 years of age at enrolment on the prevalence of anemia in a population setting; and 2) To evaluate the impact of supplementation with MMN from preconception and life skills education among young women 15-24 years of age on the rate of low birth weight (LBW) in a population setting. Infants born to mothers enrolled in the study will be followed for 1 year. This study aims to enrol 25,400 non-pregnant young women in Matiari district. This sample size is anticipated to equate to 1456 births. Participants will be randomized by cluster to receive either MMN supplements and life skills education or the standard of care at enrolment. Clusters have been defined based on health facility catchment areas. MMN supplements will be provided twice weekly during the preconception period, once daily during the pregnancy period, and once daily until 6 months after giving birth during the postpartum period; and a package of life skills education materials will be provided bi-monthly during the preconception period. In addition to the primary outcomes, measurements will include micronutrient status, anthropometrics, birth outcomes, dietary intake and feeding practices, adherence, and indices of empowerment.
- Conditions
- Adolescents, Anemia, Pregnancy, Empowerment
- Being tested
- Multiple micronutrients (UNIMMAP composition), Life skills based education
- Keywords
- preconception supplementation, multiple micronutrients, low birth weight
- Medical subject headings
- Anemia, Empowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiple micronutrients (UNIMMAP composition)Dietary supplement
Also called UNICEF, Micronutrient tabs, pregnancy/PAC-1000
The intervention is an oral tablet containing 15 different vitamins and minerals at the UNIMMAP composition (includes 30 mg iron, 400 μg folic acid, 15 mg zinc, 2 mg copper, 65 μg selenium, 800 μg RE vitamin A, 1.4 mg vitamin B1, 1.4 mg vitamin B2, 18 mg niacin, 1.9 mg vitamin B6, 2.6 μg vitamin B12, 70 mg vitamin C, 5 μg vitamin D, 10 mg vitamin E and 150 μg iodine). Each tablet is small (approximately 10 mm diameter) and has been procured using the UNICEF supply catalogue. A single MMN supplementation dose will consist of a single tablet.
Life skills based educationBehavioural
The life skills based education will be provided bi-monthly in the format of a group session throughout the preconception period. Three topic areas related to empowerment have been prioritized, including preventing early marriage; personal and menstrual hygiene practices; and the importance of nutrition to good health. Integrated within these topics will be messages related to the importance of continuing one's education, mental health, gender norms and equality, decision making, advocacy, resiliency, participation, communication skills, facing challenges, agency, conflict resolution, and the prevention of violence.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | No intervention | 1. Preconception period: none 2. Pregnancy period: daily iron (60 mg) and folic acid (400 µg) supplementation from confirmation of pregnancy; daily balanced energy protein supplements will additionally be provided to those participants who are underweight at the confirmation of pregnancy for the duration of the pregnancy 3. Postpartum period: daily iron and folic acid supplementation to 6 months postpartum |
| MMN supplementation and life skills education | Experimental | 1. Preconception period: twice-weekly MMN supplementation and bi-monthly group session including life skill based education materials
2. Pregnancy period: daily MMN supplementation from confirmation of pregnancy; daily balanced energy protein supplements will additionally be provided to those participants who are underweight at the confirmation of pregnancy for the duration of the pregnancy
3. Postpartum period: daily MMN supplementation to 6 months postpartum Receives: Dietary Supplement: Multiple micronutrients (UNIMMAP composition); Behavioral: Life skills based education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anemia status
Hemoglobin concentration <12 g/dL
Measured: 0, 12*, 24 months (*in subgroup only)
Low birth weight
Birth weight <2500 g
Measured: At birth
Secondary outcomes (21)
Biomarkers: serum ferritin, serum transferrin receptor, hepcidin, serum retinol, serum 25(OH)D, alpha-glycolytic protein, C-reactive protein (women)
Measured: Preconception (subgroup only): enrolment, 1 year, 2 years; Pregnancy: 4-12 weeks, 32 weeks; Postpartum: 1 week
Anthropometrics: height (women)
Measured: Preconception: enrolment, 6 months*, 1 year, 2 years (*in subgroup only); Pregnancy: 4-12 weeks, 32 weeks; Postpartum: 1 week, 6 months
Anthropometrics: middle upper arm circumference (women)
Measured: Preconception: enrolment, 6 months*, 1 year, 2 years (*in subgroup only); Pregnancy: 4-12 weeks, 32 weeks; Postpartum: 1 week, 6 months
Anthropometrics: weight (women)
Measured: Preconception: enrolment, 6 months*, 1 year, 2 years (*in subgroup only); Pregnancy: 4-12 weeks, 32 weeks; Postpartum: 1 week, 6 months
Gestational age
Measured: At birth
Preterm birth
Measured: At birth
Stillbirth
Measured: At birth
Small for gestational age
Measured: At birth
Birth size: length
Measured: Within 24 hours of birth
Birth size: head circumference
Measured: Within 24 hours of birth
Birth size: middle upper arm circumference
Measured: Within 24 hours of birth
Birth size: weight
Measured: Within 24 hours of birth
Birth defects
Measured: At birth
Infant growth: length
Measured: 1, 3, 6, 9, 12 months
Infant growth: head circumference
Measured: 1, 3, 6, 9, 12 months
Infant growth: middle upper arm circumference
Measured: 1, 3, 6, 9, 12 months
Infant growth: weight
Measured: 1, 3, 6, 9, 12 months
Age at marriage
Measured: Enrolment, 1 year, 2 years
Completion of 10th grade education
Measured: Enrolment, 1 year, 2 years
Use of sanitary pad during last menstrual period
Measured: Enrolment, 1 year, 2 years
Dietary intake: 24-hour recall (subgroup of women)
Measured: Preconception: enrolment; Pregnancy: 4-12 weeks, 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2017
- Study start30 Jun 2017
- Primary completion12 Mar 2021
- Study completionFeb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for AdolescentsStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 25,447 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- The Hospital for Sick Children, National Program for Family Planning and Primary Health Care, Bill and Melinda Gates Foundation
- Responsible party
- Principal investigator, Dr Zulfiqar Ahmed Bhutta, Aga Khan University
- Investigators
- Zulfiqar A Bhutta, PhD, MBBS, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03287882
- Sponsor's protocol ID
- 4324-Ped-ERC-16
- Status last verified
- Jul 2021
- First submitted
- 21 Aug 2017
- Last updated
- 27 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Baxter JB, Wasan Y, Daniel AI, Begum K, Hussain A, Iqbal J, Aufreiter S, Beggs MR, Duan L, Greco A, Huang C, Soofi S, Bandsma RH, Bhutta ZA, O'Connor DL. Maternal multiple micronutrient supplementation in rural Pakistan increased some milk micronutrient concentrations, but not infant growth, at three-months postpartum: a randomized controlled trial substudy. Am J Clin Nutr. 2025 Jul;122(1):174-184. doi: 10.1016/j.ajcnut.2025.05.019. Epub 2025 May 21.
PubMed 40409469Baxter JB, Wasan Y, Hussain A, Soofi SB, Ahmed I, Bhutta ZA. Drivers of malnutrition among late adolescent and young women in rural Pakistan: a cross-sectional assessment of the MaPPS trial. BMJ Open. 2023 May 23;13(5):e063734. doi: 10.1136/bmjopen-2022-063734.
PubMed 37221027Baxter JB, Kortenaar JL, Wasan Y, Hussain A, Soofi SB, Ahmed I, Bhutta ZA. Age-Based Anthropometric Cutoffs Provide Inconsistent Estimates of Undernutrition: Findings from a Cross-Sectional Assessment of Late-Adolescent and Young Women in Rural Pakistan. Curr Dev Nutr. 2021 Nov 10;5(11):nzab130. doi: 10.1093/cdn/nzab130. eCollection 2021 Nov.
PubMed 34901693Bhutta ZA. Reply to NF Krebs and KM Hambidge. Am J Clin Nutr. 2019 Aug 1;110(2):521-522. doi: 10.1093/ajcn/nqz078. No abstract available.
PubMed 31367763Bhutta ZA. Balancing the benefits of maternal nutritional interventions; time to put women first! Am J Clin Nutr. 2019 Feb 1;109(2):249-250. doi: 10.1093/ajcn/nqy336. No abstract available.
PubMed 30721972Baxter JB, Wasan Y, Soofi SB, Suhag Z, Bhutta ZA. Effect of life skills building education and micronutrient supplements provided from preconception versus the standard of care on low birth weight births among adolescent and young Pakistani women (15-24 years): a prospective, population-based cluster-randomized trial. Reprod Health. 2018 May 31;15(1):104. doi: 10.1186/s12978-018-0545-0.
PubMed 29855317Baxter JB, Wasan Y, Soofi SB, Suhag Z, Bhutta ZA. Feasibility and effect of life skills building education and multiple micronutrient supplements versus the standard of care on anemia among non-pregnant adolescent and young Pakistani women (15-24 years): a prospective, population-based cluster-randomized trial. Reprod Health. 2018 May 30;15(1):103. doi: 10.1186/s12978-018-0547-y.
PubMed 29848335
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Cluster Randomized Effectiveness Trial of Multiple Micronutrient Supplementation and Life Skills Education Provided From Preconception on Health and Nutrition Outcomes of Young, Reproductive-age Pakistani Women (15-24 Years)
- ClinicalTrials.gov ID
- NCT03287882
- Acronym / sponsor ID
- 4324-Ped-ERC-16
- Conditions
- Adolescents, Anemia, Pregnancy, Empowerment
- Keywords
- preconception supplementation, multiple micronutrients, low birth weight
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25,447 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- The Hospital for Sick Children, National Program for Family Planning and Primary Health Care, Bill and Melinda Gates Foundation
- Study start
- 30 Jun 2017 (actual)
- Primary completion
- 12 Mar 2021 (actual)
- Study completion
- Feb 2022 (estimated)
- First posted
- 19 Sep 2017 (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.
The primary aims of this study are: 1) To evaluate the impact of supplementation with multiple micronutrients (MMN) from preconception and life skills education among women 15-18.9 years of age at enrolment on the prevalence of anemia in a population setting; and 2) To evaluate the impact of supplementation with MMN from preconception and life skills education among young women 15-24 years of age on the rate of low birth weight (LBW) in a population setting. Infants born to mothers enrolled in the study will be followed for 1 year. This study aims to enrol 25,400 non-pregnant young women in Matiari district. This sample size is anticipated to equate to 1456 births. Participants will be randomized by cluster to receive either MMN supplements and life skills education or the standard of care at enrolment. Clusters have been defined based on health facility catchment areas. MMN supplements will be provided twice weekly during the preconception period, once daily during the pregnancy period, and once daily until 6 months after giving birth during the postpartum period; and a package of life skills education materials will be provided bi-monthly during the preconception period. In addition to the primary outcomes, measurements will include micronutrient status, anthropometrics, birth outcomes, dietary intake and feeding practices, adherence, and indices of empowerment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care | No intervention | –1. Preconception period: none 2. Pregnancy period: daily iron (60 mg) and folic acid (400 µg) supplementation from confirmation of pregnancy; daily balanced energy protein supplements will additionally be provided to those participants who are underweight at the confirmation of pregnancy for the duration of the pregnancy 3. Postpartum period: daily iron and folic acid supplementation to 6 months postpartum |
| MMN supplementation and life skills education | Experimental | Dietary Supplement: Multiple micronutrients (UNIMMAP composition), Behavioral: Life skills based education1. Preconception period: twice-weekly MMN supplementation and bi-monthly group session including life skill based education materials 2. Pregnancy period: daily MMN supplementation from confirmation of pregnancy; daily balanced energy protein supplements will additionally be provided to those participants who are underweight at the confirmation of pregnancy for the duration of the pregnancy 3. Postpartum period: daily MMN supplementation to 6 months postpartum |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Minimum age at enrolment: 15 years
- Maximum age at enrolment: 23 years
- Any marital status
- Intend to comply with study intervention and follow up
Key exclusion criteria (3 listed)
- Women participating in other nutrition trials
- Women who intend to leave the study area
- Women who are already pregnant
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 |
|---|---|---|
| Multiple micronutrients (UNIMMAP composition)Also: UNICEF, Micronutrient tabs, pregnancy/PAC-1000The intervention is an oral tablet containing 15 different vitamins and minerals at the UNIMMAP composition (includes 30 mg iron, 400 μg folic acid, 15 mg zinc, 2 mg copper, 65 μg selenium, 800 μg RE vitamin A, 1.4 mg vitamin B1, 1.4 mg vitamin B2, 18 mg niacin, 1.9 mg vitamin B6, 2.6 μg vitamin B12, 70 mg vitamin C, 5 μg vitamin D, 10 mg vitamin E and 150 μg iodine). Each tablet is small (approximately 10 mm diameter) and has been procured using the UNICEF supply catalogue. A single MMN supplementation dose will consist of a single tablet. | Dietary supplement | MMN supplementation and life skills education |
| Life skills based educationThe life skills based education will be provided bi-monthly in the format of a group session throughout the preconception period. Three topic areas related to empowerment have been prioritized, including preventing early marriage; personal and menstrual hygiene practices; and the importance of nutrition to good health. Integrated within these topics will be messages related to the importance of continuing one's education, mental health, gender norms and equality, decision making, advocacy, resiliency, participation, communication skills, facing challenges, agency, conflict resolution, and the prevention of violence. | Behavioural | MMN supplementation and life skills education |
Primary outcome
Anemia status
Time frame: 0, 12*, 24 months (*in subgroup only)
Hemoglobin concentration <12 g/dL
Low birth weight
Time frame: At birth
Birth weight <2500 g
21 secondary outcomes
Biomarkers: serum ferritin, serum transferrin receptor, hepcidin, serum retinol, serum 25(OH)D, alpha-glycolytic protein, C-reactive protein (women)
Time frame: Preconception (subgroup only): enrolment, 1 year, 2 years; Pregnancy: 4-12 weeks, 32 weeks; Postpartum: 1 week
Anthropometrics: height (women)
Time frame: Preconception: enrolment, 6 months*, 1 year, 2 years (*in subgroup only); Pregnancy: 4-12 weeks, 32 weeks; Postpartum: 1 week, 6 months
Anthropometrics: middle upper arm circumference (women)
Time frame: Preconception: enrolment, 6 months*, 1 year, 2 years (*in subgroup only); Pregnancy: 4-12 weeks, 32 weeks; Postpartum: 1 week, 6 months
Anthropometrics: weight (women)
Time frame: Preconception: enrolment, 6 months*, 1 year, 2 years (*in subgroup only); Pregnancy: 4-12 weeks, 32 weeks; Postpartum: 1 week, 6 months
Gestational age
Time frame: At birth
Preterm birth
Time frame: At birth
Stillbirth
Time frame: At birth
Small for gestational age
Time frame: At birth
Birth size: length
Time frame: Within 24 hours of birth
Birth size: head circumference
Time frame: Within 24 hours of birth
Birth size: middle upper arm circumference
Time frame: Within 24 hours of birth
Birth size: weight
Time frame: Within 24 hours of birth
Birth defects
Time frame: At birth
Infant growth: length
Time frame: 1, 3, 6, 9, 12 months
Infant growth: head circumference
Time frame: 1, 3, 6, 9, 12 months
Infant growth: middle upper arm circumference
Time frame: 1, 3, 6, 9, 12 months
Infant growth: weight
Time frame: 1, 3, 6, 9, 12 months
Age at marriage
Time frame: Enrolment, 1 year, 2 years
Completion of 10th grade education
Time frame: Enrolment, 1 year, 2 years
Use of sanitary pad during last menstrual period
Time frame: Enrolment, 1 year, 2 years
Dietary intake: 24-hour recall (subgroup of women)
Time frame: Preconception: enrolment; Pregnancy: 4-12 weeks, 32 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
- Derived from this study: PubMed 40409469Baxter JB, Wasan Y, Daniel AI, Begum K, Hussain A, Iqbal J, Aufreiter S, Beggs MR, Duan L, Greco A, Huang C, Soofi S, Bandsma RH, Bhutta ZA, O'Connor DL. Maternal multiple micronutrient supplementation in rural Pakistan increased some milk micronutrient concentrations, but not infant growth, at three-months postpartum: a randomized controlled trial substudy. Am J Clin Nutr. 2025 Jul;122(1):174-184. doi: 10.1016/j.ajcnut.2025.05.019. Epub 2025 May 21.
- Derived from this study: PubMed 37221027Baxter JB, Wasan Y, Hussain A, Soofi SB, Ahmed I, Bhutta ZA. Drivers of malnutrition among late adolescent and young women in rural Pakistan: a cross-sectional assessment of the MaPPS trial. BMJ Open. 2023 May 23;13(5):e063734. doi: 10.1136/bmjopen-2022-063734.
- Derived from this study: PubMed 34901693Baxter JB, Kortenaar JL, Wasan Y, Hussain A, Soofi SB, Ahmed I, Bhutta ZA. Age-Based Anthropometric Cutoffs Provide Inconsistent Estimates of Undernutrition: Findings from a Cross-Sectional Assessment of Late-Adolescent and Young Women in Rural Pakistan. Curr Dev Nutr. 2021 Nov 10;5(11):nzab130. doi: 10.1093/cdn/nzab130. eCollection 2021 Nov.
- Derived from this study: PubMed 31367763Bhutta ZA. Reply to NF Krebs and KM Hambidge. Am J Clin Nutr. 2019 Aug 1;110(2):521-522. doi: 10.1093/ajcn/nqz078. No abstract available.
- Derived from this study: PubMed 30721972Bhutta ZA. Balancing the benefits of maternal nutritional interventions; time to put women first! Am J Clin Nutr. 2019 Feb 1;109(2):249-250. doi: 10.1093/ajcn/nqy336. No abstract available.
- Derived from this study: PubMed 29855317Baxter JB, Wasan Y, Soofi SB, Suhag Z, Bhutta ZA. Effect of life skills building education and micronutrient supplements provided from preconception versus the standard of care on low birth weight births among adolescent and young Pakistani women (15-24 years): a prospective, population-based cluster-randomized trial. Reprod Health. 2018 May 31;15(1):104. doi: 10.1186/s12978-018-0545-0.
- Derived from this study: PubMed 29848335Baxter JB, Wasan Y, Soofi SB, Suhag Z, Bhutta ZA. Feasibility and effect of life skills building education and multiple micronutrient supplements versus the standard of care on anemia among non-pregnant adolescent and young Pakistani women (15-24 years): a prospective, population-based cluster-randomized trial. Reprod Health. 2018 May 30;15(1):103. doi: 10.1186/s12978-018-0547-y.
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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.
Zulfiqar A Bhutta, PhD, MBBS principal investigator
Aga Khan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Multiple micronutrients (UNIMMAP composition) and Life skills based education in people with Adolescents and Anemia, run by Aga Khan University at 1 site in Pakistan.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 27 Jul 2021. 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 Pakistan. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Anemia status (time frame: 0, 12*, 24 months (*in subgroup only)). The study lists 2 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 NCT03287882, which also lists 7 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 27 Jul 2021.