HealthyNCT00531674
Efficacy of 3 Nutritional Supplements to Improve Diverse Outcomes in Children Under 2 Years of Age and Pregnant Women
A study testing fortified milk-based beverage, Sprinkles and tablets in people with Healthy, run by Mexican National Institute of Public Health.
Trial summary
The Mexican poverty alleviation program, Oportunidades provides a fortified food supplement to all beneficiary children under 2 years of age, and all pregnant and lactating women. Read more about this study
- Who is it for?
- Ages 6 to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- fortified milk-based beverage, Sprinkles and tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 2005to Oct 2007
- 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 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Pregnant women before 27 wks pregnancy (Arm 1)
- 18 yrs of age and older (Arm 1)
- Children 6 to 12 mo of age (Arm 2)
- Beneficiaries of the Oportunidades programa (Arm 1 and 2)
Who cannot join
- Severe anemia (Arm 1 and 2)
- Consuming other nutritional supplements and unwilling to descontinue use (Arm 1 and 2)
About this study
The Mexican poverty alleviation program, Oportunidades provides a fortified food supplement to all beneficiary children under 2 years of age, and all pregnant and lactating women. Consumption of the supplements is well below recommended levels and the impact of the program on child growth and anemia is less than anticipated. This is likely due to a high degree of dilution by sharing of the supplements with other family members. We have also found evidence of a very high prevalence of overweight and obesity among beneficiaries of Oportunidades in both women and children.
Given the micronutrient content of the fortified food, it is likely that the impact of the program on child growth and the micronutrient status of women and children would improve considerable if the supplements were consumed daily in the recommended dose. This may be difficult, given the wide-spread sharing within households - something that has been identified by many beneficiary families as a desirable behavior. At the same time, we do not know whether daily consumption of the food, which contains approximately 20% of daily energy requirements, may contribute to undesirable weight gain in this population.
In this context, we have designed a cluster randomized controlled efficacy trail to compare the nutritional impact, acceptability and use of three nutritional supplements. Supplements were randomly assigned at the community level (n=54), and pregnant women (n=750) and children 6 to 12 mo of age (n=900) invited to participate. The principal objective of the study is to compare the impact of Sprinkles and Nutrisano/Nutrivida using syrup/pills as a positive control group, on child growth, weight gain and retention in pregnant women, and micronutrient status of women and children. We hypothesize that weight gain will be greater in the food group compared to the other two supplementation groups, but impacts on micronutrient status and length growth in children will be similar.
- Conditions
- Healthy
- Being tested
- fortified milk-based beverage, Sprinkles, tablets, Fortified milk-based pap, Syrup
- Keywords
- Efficacy of public health intervention (nutrition)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fortified milk-based beverageDietary supplement
Also called Nutrivida
Fortified with multiple vitamins and minerals (1 RDA). Identifical dose and formulation as other supplements for women.
SprinklesDietary supplement
Also called Vita-mine for pregnant and lactating women
Powder with multiple vitamins and minerals (1 RDA). Identifical dose and formulation as other supplements for women.
tabletsDietary supplement
Multiple vitamins and minerals (1 RDA). Identifical dose and formulation as other supplements for women.
Fortified milk-based papDietary supplement
Also called Nutrisano
Fortified with multiple vitamins and minerals (1 RDA). Identifical dose and formulation as other supplements for children.
SprinklesDietary supplement
Also called Vita-mine for children
Powder with multiple vitamins and minerals (1 RDA). Identifical dose and formulation as other supplements for women.
SyrupDietary supplement
Multiple vitamins and minerals (1 RDA). Identifical dose and formulation as other supplements for women.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Nutritional supplementation for pregnant and lactating women Receives: Dietary Supplement: fortified milk-based beverage; Dietary Supplement: Sprinkles; Dietary Supplement: tablets |
| 2 | Experimental | Nutritional supplementation for children Receives: Dietary Supplement: Fortified milk-based pap; Dietary Supplement: Sprinkles; Dietary Supplement: Syrup |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child linear growth and weight gain
Child height and weight at 24 mo of age and increment from baseline to 24 mo of age
Measured: 24 mo of age
Child hemoglobin concentration and anemia prevalence
Measured: 10 mo of supplementation, at 24 mo of age, 6 mo after completion of supplementation (30 mo of age)
Pregnancy weight gain and weight retention
Measured: 37 wks pregnancy, 1 and 3 mo postpartum
Hemoglobin concentration and anemia prevalence
Measured: 37 wks pregnancy and 1 mo postpartum
Secondary outcomes (3)
Acceptability and use of the supplements (women and children)
Measured: Children: after 2, 6 and 12 mo consumption; Women: following completion of trial and in pregnant women who did not participate in main study
Physical activity in children
Measured: after 4 and 12 mo of supplementation
Language adquisition and motor milestone development in children
Measured: Throughout follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2007 (estimated)
- Study startSep 2005
- Primary completionOct 2007
- Study completionOct 2007
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 HealthyStudies 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
Sponsor and investigators
- Lead sponsor
- Mexican National Institute of Public Health
- Sponsor type
- Other government
- Collaborators
- Secretary of Social Development, Inter-American Development Bank
- Investigators
- Lynnette M Neufeld, PhD, Principal investigator, National Institute of public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00531674
- Sponsor's protocol ID
- NIPH472
- Status last verified
- Nov 2012
- First submitted
- 18 Sep 2007
- Last updated
- 7 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Neufeld LM, Garcia-Guerra A, Quezada AD, Theodore F, Bonvecchio Arenas A, Islas CD, Garcia-Feregrino R, Hernandez A, Colchero A, Habicht JP. A Fortified Food Can Be Replaced by Micronutrient Supplements for Distribution in a Mexican Social Protection Program Based on Results of a Cluster-Randomized Trial and Costing Analysis. J Nutr. 2019 Dec 1;149(Suppl 1):2302S-2309S. doi: 10.1093/jn/nxz176.
PubMed 31793645
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of 3 Nutritional Supplements to Improve Diverse Outcomes in Children Under 2 Years of Age and Pregnant Women
- ClinicalTrials.gov ID
- NCT00531674
- Acronym / sponsor ID
- NIPH472
- Conditions
- Healthy
- Keywords
- Efficacy of public health intervention (nutrition)
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Mexican National Institute of Public HealthOther government
- Collaborators
- Secretary of Social Development, Inter-American Development Bank
- Study start
- Sep 2005
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 19 Sep 2007 (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.
The Mexican poverty alleviation program, Oportunidades provides a fortified food supplement to all beneficiary children under 2 years of age, and all pregnant and lactating women. Consumption of the supplements is well below recommended levels and the impact of the program on child growth and anemia is less than anticipated. This is likely due to a high degree of dilution by sharing of the supplements with other family members. We have also found evidence of a very high prevalence of overweight and obesity among beneficiaries of Oportunidades in both women and children.
Given the micronutrient content of the fortified food, it is likely that the impact of the program on child growth and the micronutrient status of women and children would improve considerable if the supplements were consumed daily in the recommended dose. This may be difficult, given the wide-spread sharing within households - something that has been identified by many beneficiary families as a desirable behavior. At the same time, we do not know whether daily consumption of the food, which contains approximately 20% of daily energy requirements, may contribute to undesirable weight gain in this population.
In this context, we have designed a cluster randomized controlled efficacy trail to compare the nutritional impact, acceptability and use of three nutritional supplements. Supplements were randomly assigned at the community level (n=54), and pregnant women (n=750) and children 6 to 12 mo of age (n=900) invited to participate. The principal objective of the study is to compare the impact of Sprinkles and Nutrisano/Nutrivida using syrup/pills as a positive control group, on child growth, weight gain and retention in pregnant women, and micronutrient status of women and children. We hypothesize that weight gain will be greater in the food group compared to the other two supplementation groups, but impacts on micronutrient status and length growth in children will be similar.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: fortified milk-based beverage, Dietary Supplement: Sprinkles, Dietary Supplement: tabletsNutritional supplementation for pregnant and lactating women |
| 2 | Experimental | Dietary Supplement: Fortified milk-based pap, Dietary Supplement: Sprinkles, Dietary Supplement: SyrupNutritional supplementation for children |
Who may qualify
- Ages
- 6 to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Pregnant women before 27 wks pregnancy (Arm 1)
- 18 yrs of age and older (Arm 1)
- Children 6 to 12 mo of age (Arm 2)
- Beneficiaries of the Oportunidades programa (Arm 1 and 2)
Key exclusion criteria (2 listed)
- Severe anemia (Arm 1 and 2)
- Consuming other nutritional supplements and unwilling to descontinue use (Arm 1 and 2)
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 |
|---|---|---|
| fortified milk-based beverageAlso: NutrividaFortified with multiple vitamins and minerals (1 RDA). Identifical dose and formulation as other supplements for women. | Dietary supplement | 1 |
| SprinklesAlso: Vita-mine for pregnant and lactating womenPowder with multiple vitamins and minerals (1 RDA). Identifical dose and formulation as other supplements for women. | Dietary supplement | 1 |
| tabletsMultiple vitamins and minerals (1 RDA). Identifical dose and formulation as other supplements for women. | Dietary supplement | 1 |
| Fortified milk-based papAlso: NutrisanoFortified with multiple vitamins and minerals (1 RDA). Identifical dose and formulation as other supplements for children. | Dietary supplement | 2 |
| SprinklesAlso: Vita-mine for childrenPowder with multiple vitamins and minerals (1 RDA). Identifical dose and formulation as other supplements for women. | Dietary supplement | 2 |
| SyrupMultiple vitamins and minerals (1 RDA). Identifical dose and formulation as other supplements for women. | Dietary supplement | 2 |
Primary outcome
Child linear growth and weight gain
Time frame: 24 mo of age
Child height and weight at 24 mo of age and increment from baseline to 24 mo of age
Child hemoglobin concentration and anemia prevalence
Time frame: 10 mo of supplementation, at 24 mo of age, 6 mo after completion of supplementation (30 mo of age)
Pregnancy weight gain and weight retention
Time frame: 37 wks pregnancy, 1 and 3 mo postpartum
Hemoglobin concentration and anemia prevalence
Time frame: 37 wks pregnancy and 1 mo postpartum
3 secondary outcomes
Acceptability and use of the supplements (women and children)
Time frame: Children: after 2, 6 and 12 mo consumption; Women: following completion of trial and in pregnant women who did not participate in main study
Physical activity in children
Time frame: after 4 and 12 mo of supplementation
Language adquisition and motor milestone development in children
Time frame: Throughout follow-up
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 7 Nov 2014.
- Derived from this study: PubMed 31793645Neufeld LM, Garcia-Guerra A, Quezada AD, Theodore F, Bonvecchio Arenas A, Islas CD, Garcia-Feregrino R, Hernandez A, Colchero A, Habicht JP. A Fortified Food Can Be Replaced by Micronutrient Supplements for Distribution in a Mexican Social Protection Program Based on Results of a Cluster-Randomized Trial and Costing Analysis. J Nutr. 2019 Dec 1;149(Suppl 1):2302S-2309S. doi: 10.1093/jn/nxz176.
- Home page, National Institute of Public Health, MexicoLink provided by the sponsor.
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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.
Lynnette M Neufeld, PhD principal investigator
National Institute of public Health
Questions about this trial
What is this clinical trial studying?
A study testing fortified milk-based beverage, Sprinkles and tablets in people with Healthy, run by Mexican National Institute of Public Health.
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 7 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Child linear growth and weight gain (time frame: 24 mo of age). The study lists 4 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 NCT00531674, 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 7 Nov 2014.