Nutritional DeficienciesGrowSmartNCT01660958
Project Grow Smart: Intervention Trial of Multiple Micronutrients and Early Learning Among Infants in India
A study testing MNP and Early Learning in people with Nutritional Deficiencies and Developmental Delay, run by University of Maryland, Baltimore at 1 site in India.
Trial summary
Project Grow Smart evaluates the impact fortification with multiple micronutrient powders (MNP) vs. placebo (one vitamin) on child development (primary outcome) and on micronutrient status, growth, and morbidity (secondary outcomes) among young children in rural India (Nalgonda district of Telegana). Read more about this study
- Who is it for?
- Ages 6 to 48 monthsHealthy volunteers can take part
- Conditions the study is for
- Nutritional Deficiencies, Developmental Delay
- What is being tested?
- MNP and Early Learning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 834 participants
- Where
- 1 siteIndia
- Study dates
- Aug 2012to Dec 2014
- 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 6 to 48 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Participating children must be in one of two age groups: infants: 6-14 months or preschoolers: 30-48 months, inclusive, at time of recruitment.
- Participants must reside in the Nalgonda district of Telengana, India.
- Preschoolers must attend an Anganwadi Center (preschool) in the Nalgonda district that is participating in Project Grow Smart.
- Participating caregivers must be at least 18 years of age at the time of recruitment.
Who cannot join
- Children with chronic diseases, developmental disabilities, mental retardation, or severe physical handicaps will be excluded
- Children with severe stunting ( <= -3 standard deviation of length-for-age z-score) or severe anemia (hemoglobin < 7 g/dl) will be excluded and referred to a local hospital for evaluation and intervention, as needed..
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Innovative Strategies to Promote Early Child Development Among Low-income Rural Infants and Preschoolers in India Through Multiple Micronutrient Fortification and Early Learning Opportunities
Project Grow Smart evaluates the impact fortification with multiple micronutrient powders (MNP) vs. placebo (one vitamin) on child development (primary outcome) and on micronutrient status, growth, and morbidity (secondary outcomes) among young children in rural India (Nalgonda district of Telegana). There is an infant phase and a preschool phase; investigators, study team members, and participants are unaware of whether the fortification is MNP vs. placebo.
The infant phase (enrollment age: 6-14 months) is a 4-cell factorial randomized trial (MNP vs. placebo and early learning vs. routine care), conducted through home visits. Sachets (MNP/placebo) are distributed to be mixed with food. The hypotheses in the infant phase are: 1) MNP leads to better development, growth, and micronutrient status; 2) Early learning leads to better development; 3) Integrated MNP plus early learning leads to better development through both additive and synergistic processes. Developmental evaluations and anthropometric measurements are conducted at baseline, mid-line (6 months), and end-line (12 months). Blood draws for micronutrient status are performed at baseline and endline. Morbidity measures are collected monthly using a morbidity form, modeled after the Demographic and Health Survey.
The preschool phase (enrollment age: 30-48 months) is conducted in Anganwadi Centers (AWC) (preschools). AWC are classified as high or low stimulation, based on an objective observational rating system of the physical environment of the preschools and teacher-child interactions. Preschools are categorized into high/low-quality based on median split, followed by random assignment of MNP/placebo nested within high/low-quality preschools. The hypotheses in the preschool phase are: 1)MNP leads to better development, growth, and micronutrient status; 2) the effect of the MNP on preschoolers' development varies by the quality of the AWC, with stronger effects among preschoolers in high-quality AWCs. The intervention has been modified to coincide with the academic term (September-May). Evaluations are conducted at baseline (September) and end-line (prior to May), with an 8-month intervention period.
Read the detailed description
Project Grow Smart has two phases: an infant phase and a preschool phase. The design of the two phases differs, although both evaluate the impact of fortification with multiple micronutrient powders (MNP) vs. placebo on child development.
In the infant phase, 6-14 month old infants are recruited and randomized into one of four cells to receive: placebo, placebo plus early learning, MNP alone, and MNP plus early learning (integrated intervention). Interventions are delivered through biweekly (twice/month) home visits by Village Level Workers. Families of all infants receive information on iron rich foods.
The preschool phase is conducted in 22 Anganwadi Centers (AWC) (i.e., preschools). AWC quality is assessed, based on a 109-item observation scale, organized into 18 categories, based on two validated scales: Early Childhood Environment Rating Scale-Revised (ECERS-R) and HOME Inventory, modified to rate the quality of learning opportunities and teacher-child interactions. After training and establishing inter-rater reliability, two psychologists spend four hours in each preschool and independently complete the observation. Scores are summed and averaged. Based on a median split, preschools are categorized into high/low-quality with random assignment of MNP/placebo nested within high/low-quality preschools. Classifications are unknown by investigators, study team, or preschools.
The preschool protocol has been modified to ensure that the trial coincides with the academic term (September-May) to avoid losing the oldest children who transfer to private or primary schools. Baseline evaluations are conducted in September and end-line evaluations are conducted prior to May. Mid-line evaluations have been eliminated. The intervention is delivered over 8 months. The MNP/placebo was supplied to preschools in identical packets of 200 grams, including two measuring spoons of 1 and 0.5 grams. Each packet includes a manufacturer-assigned alphabetic code. AWC workers mix the MNP/placebo into the first bites of the preschoolers' mid-day meal. Mothers receive information on iron-rich food.
- Conditions
- Nutritional Deficiencies, Developmental Delay
- Being tested
- MNP, Early Learning
- Keywords
- Micronutrient Deficiencies, Early Child Development, Infant Growth, Iron Deficiency
- Medical subject headings
- Malnutrition, Learning Disabilities, Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MNPDietary supplement
The formulation of the multiple micronutrient powder (MNP) was based on low micronutrient intake, low bioavailability of iron and zinc in the Indian diet, and current World Health Organization (WHO)and Indian recommendations regarding fortification and age-specific nutrient requirements. The MNP formulations were produced by a certified company in India and include: Iron, Vitamin A, Vitamin C, Folic Acid, Zinc, Vitamin B12 Vitamin B2, plus filler (maltodextrin). Placebo included riboflavin and maltodextrin.
Early LearningBehavioural
Also called Care for Development
- Infant will benefit from interventions that are based on responsive parenting, whereby caregivers respond to children's cues, provide opportunities for exploration, and engage in nurturant and reciprocal communication.
| Study group | Role | What they receive |
|---|---|---|
| Infants: MNP | Experimental | • Infants will receive sachets of multiple micronutrient powder (MNP) vs. placebo. Receives: Dietary Supplement: MNP |
| Infants: Early Learning | Experimental | • Infant will receive early learning messages delivered in the home by village level workers vs. routine care. Receives: Behavioral: Early Learning |
| Infants: No intervention | No intervention | * Placebo intervention include exposure to a single vitamin (B2 or riboflavin), plus the filler (maltodextrin). * Infant phase. Routine care - no early learning intervention |
| Infants: MNP/Early Learning | Experimental | * Infants receive the MNP plus early learning intervention by receiving MNP sachets
* Caregivers receive early learning messaged delivered at home biweekly for one year Receives: Dietary Supplement: MNP; Behavioral: Early Learning |
| Preschoolers:MNP/High qual preschool | Experimental | * Preschoolers will receive MNP fortified food in their Anganwadi Centers at the mid-day meal.
* Preschool quality will be assessed through observations using the Indian-modified ECERS and HOME Inventory for preschools. Using a median split, preschools will be classified as high/low quality. Using a randomization procedure, MNP vs. placebo will be assigned, nested within high/low-quality preschools.
* Preschools that are classified as high quality preschools. Receives: Dietary Supplement: MNP |
| Preschoolers:Placebo/High qual preschool | No intervention | * Placebo intervention include exposure to a single vitamin (B2 or riboflavin), plus the filler (maltodextrin). * Preschool quality will be assessed through observations using the Indian-modified ECERS and HOME Inventory for preschools. Using a median split, preschools will be classified as high/low quality. Using a randomization procedure, MNP vs. placebo will be assigned, nested within high/low-quality preschools. * Preschools that are classified as high quality preschools. |
| Preschoolers:MNP/Low qual preschool | Experimental | * Preschoolers will receive MNP fortified food in their Anganwadi Centers at the mid-day meal.
* Preschool quality will be assessed through observations using the Indian-modified ECERS and HOME Inventory for preschools. Using a median split, preschools will be classified as high/low quality. Using a randomization procedure, MNP vs. placebo will be assigned, nested within high/low-quality preschools.
* Preschools that are classified as low quality preschools. Receives: Dietary Supplement: MNP |
| Preschoolers:Placebo/Low qual preschool | No intervention | * Placebo intervention include exposure to a single vitamin (B2 or riboflavin), plus the filler (maltodextrin). * Preschool quality will be assessed through observations using the Indian-modified ECERS and HOME Inventory for preschools. Using a median split, preschools will be classified as high/low quality. Using a randomization procedure, MNP vs. placebo will be assigned, nested within high/low-quality preschools. * Preschools that are classified as low quality preschools. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infants: Change in cognitive, language, motor, and socio-emotional development
Data on infants' cognitive, language, motor, and socio-emotional development will be collected at baseline, the 6 month follow-up evaluation, and the 12-month follow-up evaluation using the Mullens Scales of Early Learning.
Measured: Baseline, Mid-Point (6mo post BL), and End-Point (12mo post BL)
Preschoolers: Change in cognitive, language, motor, and socio-emotional development
Data on preschoolers' cognitive, language, motor, and socio-emotional development will be collected at baseline and the 8-month follow-up evaluation using the Mullens Scales of Early Learning.
Measured: Baseline and End-Point (8mo post BL)
Secondary outcomes (6)
Infants: Change in micronutrient Status
Data on infants' micronutrient status (serum ferritin, transferrin receptor, serum zinc, C-reactive protein) and hemoglobin will be collected at baseline and the 12-month follow-up evaluation.
Measured: Baseline and End-Point (12 mo post-baseline)
Preschoolers: Change in micronutrient Status
Data on preschoolers' micronutrient status (serum ferritin, transferrin receptor, serum zinc, C-reactive protein) and hemoglobin will be collected at baseline and the 8-month follow-up evaluation.
Measured: Baseline and End-Point (8mo post BL)
Infants: Change in weight and height
Data on infants' weight and height will be collected at baseline, the 6 month follow-up evaluation, and the 12-month follow-up evaluation
Measured: Baseline, Mid-Point (6mo post BL), and End-Point (12mo post BL)
Preschoolers: Change in weight and height
Data on preschoolers' weight and height will be collected at baseline and the 8-month follow-up evaluation
Measured: Baseline and End-Point (8mo post BL)
Infants: Morbidity
Morbidity measures (acute respiratory infection and diarrhea) are conducted monthly using a morbidity form, modeled after the Demographic and Health Survey.
Measured: Baseline and once a month (for 12mo post BL)
Preschoolers: Morbidity
Morbidity measures (acute respiratory infection and diarrhea) are conducted monthly using a morbidity form, modeled after the Demographic and Health Survey.
Measured: Baseline and once a month (for 8mo post BL)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nutritional DeficienciesStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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
- Factorial
- Model description
- * The infant phase is a factorial design. * The preschool phase is a cluster-randomized trial (MNP/placebo nested within high/low-quality preschools).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 834 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Indian Council of Medical Research, The Mathile Institute for the Advancement of Human Nutrition, Micronutrient Initiative
- Responsible party
- Principal investigator, Maureen Black, University of Maryland, Baltimore
- Investigators
- Maureen M Black, PhD, Principal investigator, University of Maryland, BaltimoreMadhavan K. Nair, PhD, Principal investigator, NATIONAL INSTITUTE OF NUTRITION
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01660958
- Sponsor's protocol ID
- 00048720
- Acronym
- GrowSmart
- Status last verified
- Aug 2019
- First submitted
- 26 Jul 2012
- Last updated
- 16 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Black MM, Fernandez-Rao S, Nair KM, Balakrishna N, Tilton N, Radhakrishna KV, Ravinder P, Harding KB, Reinhart G, Yimgang DP, Hurley KM. A Randomized Multiple Micronutrient Powder Point-of-Use Fortification Trial Implemented in Indian Preschools Increases Expressive Language and Reduces Anemia and Iron Deficiency. J Nutr. 2021 Jul 1;151(7):2029-2042. doi: 10.1093/jn/nxab066.
PubMed 33880548
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Strategies to Promote Early Child Development Among Low-income Rural Infants and Preschoolers in India Through Multiple Micronutrient Fortification and Early Learning Opportunities
- ClinicalTrials.gov ID
- NCT01660958
- Acronym / sponsor ID
- GrowSmart / 00048720
- Conditions
- Nutritional Deficiencies, Developmental Delay
- Keywords
- Micronutrient Deficiencies, Early Child Development, Infant Growth, Iron Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 834 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Indian Council of Medical Research, The Mathile Institute for the Advancement of Human Nutrition, Micronutrient Initiative
- Study start
- Aug 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 9 Aug 2012 (estimated)
- 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.
Project Grow Smart evaluates the impact fortification with multiple micronutrient powders (MNP) vs. placebo (one vitamin) on child development (primary outcome) and on micronutrient status, growth, and morbidity (secondary outcomes) among young children in rural India (Nalgonda district of Telegana). There is an infant phase and a preschool phase; investigators, study team members, and participants are unaware of whether the fortification is MNP vs. placebo.
The infant phase (enrollment age: 6-14 months) is a 4-cell factorial randomized trial (MNP vs. placebo and early learning vs. routine care), conducted through home visits. Sachets (MNP/placebo) are distributed to be mixed with food. The hypotheses in the infant phase are: 1) MNP leads to better development, growth, and micronutrient status; 2) Early learning leads to better development; 3) Integrated MNP plus early learning leads to better development through both additive and synergistic processes. Developmental evaluations and anthropometric measurements are conducted at baseline, mid-line (6 months), and end-line (12 months). Blood draws for micronutrient status are performed at baseline and endline. Morbidity measures are collected monthly using a morbidity form, modeled after the Demographic and Health Survey.
The preschool phase (enrollment age: 30-48 months) is conducted in Anganwadi Centers (AWC) (preschools). AWC are classified as high or low stimulation, based on an objective observational rating system of the physical environment of the preschools and teacher-child interactions. Preschools are categorized into high/low-quality based on median split, followed by random assignment of MNP/placebo nested within high/low-quality preschools. The hypotheses in the preschool phase are: 1)MNP leads to better development, growth, and micronutrient status; 2) the effect of the MNP on preschoolers' development varies by the quality of the AWC, with stronger effects among preschoolers in high-quality AWCs. The intervention has been modified to coincide with the academic term (September-May). Evaluations are conducted at baseline (September) and end-line (prior to May), with an 8-month intervention period.
Detailed description
Project Grow Smart has two phases: an infant phase and a preschool phase. The design of the two phases differs, although both evaluate the impact of fortification with multiple micronutrient powders (MNP) vs. placebo on child development.
In the infant phase, 6-14 month old infants are recruited and randomized into one of four cells to receive: placebo, placebo plus early learning, MNP alone, and MNP plus early learning (integrated intervention). Interventions are delivered through biweekly (twice/month) home visits by Village Level Workers. Families of all infants receive information on iron rich foods.
The preschool phase is conducted in 22 Anganwadi Centers (AWC) (i.e., preschools). AWC quality is assessed, based on a 109-item observation scale, organized into 18 categories, based on two validated scales: Early Childhood Environment Rating Scale-Revised (ECERS-R) and HOME Inventory, modified to rate the quality of learning opportunities and teacher-child interactions. After training and establishing inter-rater reliability, two psychologists spend four hours in each preschool and independently complete the observation. Scores are summed and averaged. Based on a median split, preschools are categorized into high/low-quality with random assignment of MNP/placebo nested within high/low-quality preschools. Classifications are unknown by investigators, study team, or preschools.
The preschool protocol has been modified to ensure that the trial coincides with the academic term (September-May) to avoid losing the oldest children who transfer to private or primary schools. Baseline evaluations are conducted in September and end-line evaluations are conducted prior to May. Mid-line evaluations have been eliminated. The intervention is delivered over 8 months. The MNP/placebo was supplied to preschools in identical packets of 200 grams, including two measuring spoons of 1 and 0.5 grams. Each packet includes a manufacturer-assigned alphabetic code. AWC workers mix the MNP/placebo into the first bites of the preschoolers' mid-day meal. Mothers receive information on iron-rich food.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
- Model description
- * The infant phase is a factorial design. * The preschool phase is a cluster-randomized trial (MNP/placebo nested within high/low-quality preschools).
| Arm | Type | Receives |
|---|---|---|
| Infants: MNP | Experimental | Dietary Supplement: MNP• Infants will receive sachets of multiple micronutrient powder (MNP) vs. placebo. |
| Infants: Early Learning | Experimental | Behavioral: Early Learning• Infant will receive early learning messages delivered in the home by village level workers vs. routine care. |
| Infants: No intervention | No intervention | –* Placebo intervention include exposure to a single vitamin (B2 or riboflavin), plus the filler (maltodextrin). * Infant phase. Routine care - no early learning intervention |
| Infants: MNP/Early Learning | Experimental | Dietary Supplement: MNP, Behavioral: Early Learning* Infants receive the MNP plus early learning intervention by receiving MNP sachets * Caregivers receive early learning messaged delivered at home biweekly for one year |
| Preschoolers:MNP/High qual preschool | Experimental | Dietary Supplement: MNP* Preschoolers will receive MNP fortified food in their Anganwadi Centers at the mid-day meal. * Preschool quality will be assessed through observations using the Indian-modified ECERS and HOME Inventory for preschools. Using a median split, preschools will be classified as high/low quality. Using a randomization procedure, MNP vs. placebo will be assigned, nested within high/low-quality preschools. * Preschools that are classified as high quality preschools. |
| Preschoolers:Placebo/High qual preschool | No intervention | –* Placebo intervention include exposure to a single vitamin (B2 or riboflavin), plus the filler (maltodextrin). * Preschool quality will be assessed through observations using the Indian-modified ECERS and HOME Inventory for preschools. Using a median split, preschools will be classified as high/low quality. Using a randomization procedure, MNP vs. placebo will be assigned, nested within high/low-quality preschools. * Preschools that are classified as high quality preschools. |
| Preschoolers:MNP/Low qual preschool | Experimental | Dietary Supplement: MNP* Preschoolers will receive MNP fortified food in their Anganwadi Centers at the mid-day meal. * Preschool quality will be assessed through observations using the Indian-modified ECERS and HOME Inventory for preschools. Using a median split, preschools will be classified as high/low quality. Using a randomization procedure, MNP vs. placebo will be assigned, nested within high/low-quality preschools. * Preschools that are classified as low quality preschools. |
| Preschoolers:Placebo/Low qual preschool | No intervention | –* Placebo intervention include exposure to a single vitamin (B2 or riboflavin), plus the filler (maltodextrin). * Preschool quality will be assessed through observations using the Indian-modified ECERS and HOME Inventory for preschools. Using a median split, preschools will be classified as high/low quality. Using a randomization procedure, MNP vs. placebo will be assigned, nested within high/low-quality preschools. * Preschools that are classified as low quality preschools. |
Who may qualify
- Ages
- 6 to 48 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Participating children must be in one of two age groups: infants: 6-14 months or preschoolers: 30-48 months, inclusive, at time of recruitment.
- Participants must reside in the Nalgonda district of Telengana, India.
- Preschoolers must attend an Anganwadi Center (preschool) in the Nalgonda district that is participating in Project Grow Smart.
- Participating caregivers must be at least 18 years of age at the time of recruitment.
Key exclusion criteria (2 listed)
- Children with chronic diseases, developmental disabilities, mental retardation, or severe physical handicaps will be excluded
- Children with severe stunting ( <= -3 standard deviation of length-for-age z-score) or severe anemia (hemoglobin < 7 g/dl) will be excluded and referred to a local hospital for evaluation and intervention, as needed..
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 |
|---|---|---|
| MNPThe formulation of the multiple micronutrient powder (MNP) was based on low micronutrient intake, low bioavailability of iron and zinc in the Indian diet, and current World Health Organization (WHO)and Indian recommendations regarding fortification and age-specific nutrient requirements. The MNP formulations were produced by a certified company in India and include: Iron, Vitamin A, Vitamin C, Folic Acid, Zinc, Vitamin B12 Vitamin B2, plus filler (maltodextrin). Placebo included riboflavin and maltodextrin. | Dietary supplement | Infants: MNP, Infants: MNP/Early Learning, Preschoolers:MNP/High qual preschool, Preschoolers:MNP/Low qual preschool |
| Early LearningAlso: Care for Development• Infant will benefit from interventions that are based on responsive parenting, whereby caregivers respond to children's cues, provide opportunities for exploration, and engage in nurturant and reciprocal communication. | Behavioural | Infants: Early Learning, Infants: MNP/Early Learning |
Primary outcome
Infants: Change in cognitive, language, motor, and socio-emotional development
Time frame: Baseline, Mid-Point (6mo post BL), and End-Point (12mo post BL)
Data on infants' cognitive, language, motor, and socio-emotional development will be collected at baseline, the 6 month follow-up evaluation, and the 12-month follow-up evaluation using the Mullens Scales of Early Learning.
Preschoolers: Change in cognitive, language, motor, and socio-emotional development
Time frame: Baseline and End-Point (8mo post BL)
Data on preschoolers' cognitive, language, motor, and socio-emotional development will be collected at baseline and the 8-month follow-up evaluation using the Mullens Scales of Early Learning.
6 secondary outcomes
Infants: Change in micronutrient Status
Time frame: Baseline and End-Point (12 mo post-baseline)
Preschoolers: Change in micronutrient Status
Time frame: Baseline and End-Point (8mo post BL)
Infants: Change in weight and height
Time frame: Baseline, Mid-Point (6mo post BL), and End-Point (12mo post BL)
Preschoolers: Change in weight and height
Time frame: Baseline and End-Point (8mo post BL)
Infants: Morbidity
Time frame: Baseline and once a month (for 12mo post BL)
Preschoolers: Morbidity
Time frame: Baseline and once a month (for 8mo post BL)
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 16 Aug 2019.
- Derived from this study: PubMed 33880548Black MM, Fernandez-Rao S, Nair KM, Balakrishna N, Tilton N, Radhakrishna KV, Ravinder P, Harding KB, Reinhart G, Yimgang DP, Hurley KM. A Randomized Multiple Micronutrient Powder Point-of-Use Fortification Trial Implemented in Indian Preschools Increases Expressive Language and Reduces Anemia and Iron Deficiency. J Nutr. 2021 Jul 1;151(7):2029-2042. doi: 10.1093/jn/nxab066.
Related trials for Nutritional Deficiencies
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
RecruitingPhase 1/2
Study is to Assess the Safety and Tolerability of VTx-002 in Participants With ALS
Amyotrophic Lateral Sclerosis
Not yet recruiting
A Study on the Addition of Alsum30 for the Treatment of Amyotrophic Lateral Sclerosis
Amyotrophic Lateral Sclerosis (ALS), Bacillus Coagulans
Active, not recruiting
Functional Outcomes and Control Using Synchron BCI - Australia
Neurologic Disorder, Neurologic Diseases
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.
Maureen M Black, PhD principal investigator
University of Maryland, Baltimore
Madhavan K. Nair, PhD principal investigator
NATIONAL INSTITUTE OF NUTRITION
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MNP and Early Learning in people with Nutritional Deficiencies and Developmental Delay, run by University of Maryland, Baltimore 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 4 inclusion and 2 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 16 Aug 2019. 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?
Infants: Change in cognitive, language, motor, and socio-emotional development (time frame: Baseline, Mid-Point (6mo post BL), and End-Point (12mo post BL)). 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 NCT01660958, which also lists 1 linked publication.
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 16 Aug 2019.