Efficacy of 3 Nutritional Supplements to Improve Diverse Outcomes in Children Under 2 Years of Age and Pregnant Women

Study Overview
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Brief Summary
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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
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Healthy

Intervention / Treatment
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* Dietary Supplement: fortified milk-based beverage
* Dietary Supplement: Sprinkles
* Dietary Supplement: tablets
* Dietary Supplement: Fortified milk-based pap
* Dietary Supplement: Sprinkles
* Dietary Supplement: Syrup


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: Severe anemia (Arm 1 and 2) Consuming other nutritional supplements and unwilling to descontinue use (Arm 1 and 2)

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Nutritional supplementation for pregnant and lactating women | Dietary Supplement: fortified milk-based beverage<br>* Fortified with multiple vitamins and minerals (1 RDA). Identifical dose and formulation as other supplements for women.<br>* Other names: Nutrivida;Dietary Supplement: Sprinkles<br>* Powder with multiple vitamins and minerals (1 RDA). Identifical dose and formulation as other supplements for women.<br>* Other names: Vita-mine for pregnant and lactating women;Dietary Supplement: tablets<br>* Multiple vitamins and minerals (1 RDA). Identifical dose and formulation as other supplements for women.<br>|
| Experimental: 2<br>Nutritional supplementation for children | Dietary Supplement: Fortified milk-based pap<br>* Fortified with multiple vitamins and minerals (1 RDA). Identifical dose and formulation as other supplements for children.<br>* Other names: Nutrisano;Dietary Supplement: Sprinkles<br>* Powder with multiple vitamins and minerals (1 RDA). Identifical dose and formulation as other supplements for women.<br>* Other names: Vita-mine for children;Dietary Supplement: Syrup<br>* Multiple vitamins and minerals (1 RDA). Identifical dose and formulation as other supplements for women.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child linear growth and weight gain | Child height and weight at 24 mo of age and increment from baseline to 24 mo of age | 24 mo of age | 
| Child hemoglobin concentration and anemia prevalence |  | 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 |  | 37 wks pregnancy, 1 and 3 mo postpartum | 
| Hemoglobin concentration and anemia prevalence |  | 37 wks pregnancy and 1 mo postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability and use of the supplements (women and children) |  | 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 |  | after 4 and 12 mo of supplementation | 
| Language adquisition and motor milestone development in children |  | Throughout follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Efficacy of public health intervention (nutrition)