Nutrient and Immunity Status in Children Aged 3-5 Years Consuming Their Habitual Diet With or Without Fortified Milk

NCT05440604 | Completed

• 1 other identifier: 2020.01.INF
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

This study compares the status of key micronutrients (vitamins A, C, D, E, and zinc) in young children given investigational fortified milk versus young children consuming their habitual pattern of beverage intake (milk and non-milk beverages).

Conditions

Nutritional Status; Child Nutrition Sciences; Toddlers

Outcome Measures

Primary Outcomes (5)

• change in vitamin A status

  measure in serum retinol in μmol/L

  16 weeks

• change in vitamin C status

  measure in plasma vitamin C in mg/dL

  16 weeks

• change in vitamin D status

  measure in serum 25-hydroxy vitamin D (25\[OH\]D) in nmol/L

  16 weeks

• change in vitamin E status

  measure in plasma alpha-tocopherol in mg/L

  16 weeks

• change in zinc status

  measure in plasma zinc in μg/dl

  16 weeks

Secondary Outcomes (11)

• monitor growth and development

  16 weeks

• monitor growth and development

  16 weeks

• monitor growth and development

  16 weeks

• assess dietary intake

  4 weeks, 8 weeks, 12 weeks, 16 weeks

• assess habitual pattern of food and beverage intake

  16 weeks

Study Arms (2)

Fortified milk group

EXPERIMENTAL

2 daily servings of the investigational fortified milk for 16 weeks

Other: Fortified milk

Observational group

NO INTERVENTION

will be asked to consume beverages in accordance with their habitual pattern of intake

Interventions

Fortified milk OTHER

Commercially available milk-based fortified beverage that has an updated profile of key micronutrients along with appropriate levels of protein and other macro- and micro- nutrients, in accordance with global and local nutritional recommendations

Fortified milk group

Eligibility Criteria

• Age: 36 Months - 54 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Having obtained his/her parent's(s') or his/her legal guardian written informed consent and signed and dated informed consent.
• Child's parent(s)/guardian is/are of legal age of consent, must understand the informed consent and other study documents, and is/are willing and able to fulfill the requirements of the study protocol
• Age 3 years old to 4 years old and 6 months at enrolment
• Healthy at birth, singleton, full-term gestational birth (37-42 completed weeks of gestation), with a birth weight of 2.5 kg to 3.9 kg
• At the time of enrolment, the participant's weight-for-age, height-for-age, weight-for-height, BMI z-score should be within -2 to +1
• At the time of enrolment, the participant is in good health (no history of underlying metabolic or chronic disease; congenital malformation; or any other condition which, in the opinion of the investigator, is likely to interfere with: the ability of the child to ingest food, the normal growth and development of the child, or the evaluation of the infant; acute illness in a minor condition which are common in childhood such as viral or bacterial infection e.g. conjunctivitis, otitis media, upper/lower respiratory tract infection, gastroenteritis, hand foot \& mouth disease at time of enrolment is permitted) as determined by physical history, physical exam and judgement by the investigator
• Child's parent(s)/guardian can be contacted directly by telephone or mobile phone throughout the study

You may not qualify if:

• Chronic infectious, metabolic, genetic illness, or other disease including any condition that impacts feeding, or any outcome measures
• Child exhibits any clinical signs of potential micronutrient deficiencies (e.g., hemoglobin \< 100 g/L based on screening assessment, rickets based on physical exam).
• Known or suspected cows' milk protein intolerance / lactose intolerance /allergy or severe food allergies that impact diet
• Breast milk used exclusively / mixed in place of all other milk, and/or milk alternatives at 3 years of age
• Consuming supplement(s) of relevance to the study outcome relating diet to status, vitamins A, D, E and C; zinc
• Child's family who in the Investigator's judgment cannot be expected to comply with the protocol or study procedures

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Las Piñas Doctors Hospital

Las Piñas, National Capital Region, Philippines

Location

Study Officials

• Elvira M Estorninos, MD

  Las Piñas Doctors Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: July 1, 2022
• Study Start: June 23, 2022
• Primary Completion: December 14, 2022
• Study Completion: December 14, 2022
• Last Updated: July 20, 2023

Record last verified: 2023-07

Locations

PH (1)