Milk Supplementation and Bone Health in Children
29 september 2021 bijgewerkt door: Yu-ming Chen, Sun Yat-sen University
Effects of Yili Child Formula Milk on Bone Health in 4-6 Year Children: a 12-month Randomized Controlled Trial
Objectives: to examine the effects of a Yili child formula milk and regular milk on bone health and growth in young children.
Study design: cluster randomized controlled trial.
Setting: kindergartens in Hui-ning County of Gansu Province, China (north west).
Participants: >=246 apparent healthy children aged 4-6 years old.
Interventions:
(I) Yili child formula milk (QQ star formula, SCI-PRO NUTR5+6TM), 195 ml *2 /day; (II) Yili regular milk (pure milk), 195ml*2 /day; (III) Controls: about 50g/d grain foods (containing 20-30 g carbohydrates), e.g. bread.
Interventional Duration: 12 months.
Outcome measures: determined at 0, 6 and 12 months post treatments. Primary outcomes: bone density and bone mineral contents at the forearm and heel, bone biomarkers.
Secondary outcomes: (1) anthropometric indices: weight, height, waist circumference, etc.; (2) immune status.
Other measures: dietary intakes, physical activities, general information, medical information, adverse of side effects.
Data Analyses: The one-year changes and percent changes in the primary and secondary outcomes will be compared among the 3 groups.
Studie Overzicht
Toestand
Aanmelden op uitnodiging
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Verwacht)
254
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Gangshu
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Lanzhou, Gangshu, China, 730000
- LanZhou University
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
4 jaar tot 6 jaar (Kind)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- Aged between 4-6 years;
- female and male
- Can be enrolled into kindergarten/school as a normal child.
- Be willing to drinking milk daily.
Exclusion Criteria:
- Milk allergy or intolerance, did not to be used to drinking milk;
- Had the following diseases/conditions confirmed by a hospital: serious diseases of heart, liver, kidney, brain, hematopoietic system, immunity, thyroid or cancer that need to be hospitalization for more than 1 week or take medication(s) for more than 1 month with the past two years.
- having infectious diseases, e.g., tuberculosis, hepatitis, etc.
- Taking vitamin D, calcium tables or nutrient package;
- Consumed more than 3 times (>600ml) milk each week in the previous month.
- Be not willing to provide informed consent, or have other conditions that were considered to be unsuitable for the study by the investigators.
- Increases of body health were out of the range between 5-8 cm in the last year.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Formula Milk
Formula milk designed for young children aged over 3 years; Dosage: 195 ml/time; Frequence: 2 times /day; Duration: 12 months |
Brand name: Yili (QQ star formula milk); Type: SCI-PRO NUTRI 5+6TM formula milk designed for young children aged over 3 years; Dosage: 195ml*2/d; Intervention duration: 12 months |
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Actieve vergelijker: Regular milk
Regular milk (pure milk); Dosage: 195 ml/time; Frequence: 2 times /day; Duration: 12 months |
Brand name: Yili； Type: regular milk (pure milk); Dosage: 195ml*2/d; Intervention duration: 12 months |
|
Ander: Control foods
Grain foods: e.g., bread; Dosage: 20-40 g/time; Frequence: 2 times /day; Duration: 12 months |
Brand: N/A; Food type: grain foods (e.g., bread); Dosage: 20-40g * 2/d grain foods Intervention duration: 12 months |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change from baseline bone mineral density (BMD) at 12 months
Tijdsspanne: 0 and 12 months
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BMD (g/cm2) determined by a dual energy x-ray absorptiometry (DXA) at the left forearm and heel
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0 and 12 months
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Change from baseline bone mineral density (BMD) at 6 months
Tijdsspanne: 0 and 6 months
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BMD (g/cm2) determined by DXA at the left forearm and heel
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0 and 6 months
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Change from baseline bone mineral contents (BMC) at 12 months
Tijdsspanne: 0 and 12 months
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BMC (g) determined by DXA at the left forearm and heel.
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0 and 12 months
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Change from baseline bone mineral contents (BMC) at 6 months
Tijdsspanne: 0 and 6 months
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BMC (g) determined by DXA at the left forearm and heel.
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0 and 6 months
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Change from baseline of bone-specific alkaline phosphatase at 12 months
Tijdsspanne: 0 and 12 months
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Bone turnover marker 1: Bone-specific alkaline phosphatase
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0 and 12 months
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Change from baseline of bone-specific alkaline phosphatase at 6 months
Tijdsspanne: 0 and 6 months
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Bone turnover marker 1: Bone-specific alkaline phosphatase
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0 and 6 months
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Change from baseline of osteocalcin at 12 months
Tijdsspanne: 0 and 12 months
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Bone turnover marker 2: osteocalcin
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0 and 12 months
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Change from baseline of osteocalcin at 6 months
Tijdsspanne: 0 and 6 months
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Bone turnover marker 2: osteocalcin
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0 and 6 months
|
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Change from baseline of C-terminal telopeptide of type I collagen at 12 months
Tijdsspanne: 0 and 12 months
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Bone turnover marker 3: C-terminal telopeptide of type I collagen
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0 and 12 months
|
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Change from baseline of C-terminal telopeptide of type I collagen at 6 months
Tijdsspanne: 0 and 6 months
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Bone turnover marker 3: C-terminal telopeptide of type I collagen
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0 and 6 months
|
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Change from baseline of tartrate resistant acid phosphatase at 12 months
Tijdsspanne: 0 and 12 months
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Bone turnover marker 4: tartrate resistant acid phosphatase
|
0 and 12 months
|
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Change from baseline of tartrate resistant acid phosphatase at 6 months
Tijdsspanne: 0 and 6 months
|
Bone turnover marker 4: tartrate resistant acid phosphatase
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0 and 6 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change from baseline body weight at 12 months
Tijdsspanne: 0 and 12 months
|
Anthropometric indices: body weight
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0 and 12 months
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Change from baseline body height at 12 months
Tijdsspanne: 0 and 12 months
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Anthropometric indices: body height
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0 and 12 months
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Change from baseline biomarker of body growth at 12 months
Tijdsspanne: 0 and 12 months
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Biomarker of body growth: insulin-like growth factor 1
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0 and 12 months
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Change from baseline immune globulin M (Ig M）at 12 months
Tijdsspanne: 0 and 12 months
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Immune status: Blood Ig M
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0 and 12 months
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Change from baseline immune globulin G (Ig G）at 12 months
Tijdsspanne: 0 and 12 months
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Immune status: Blood Ig G
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0 and 12 months
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Change from baseline immune globulin G (Ig A）at 12 months
Tijdsspanne: 0 and 12 months
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Immune status: Blood Ig A
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0 and 12 months
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Change from baseline whit blood cell at 12 months
Tijdsspanne: 0 and 12 months
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Immune status: whit blood cell
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0 and 12 months
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Concentrations of blood total 25-hydroxide-vitamin D (25-OH-VD)
Tijdsspanne: 0, 6 and 12 months
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Serum 25-OH-VD
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0, 6 and 12 months
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Concentrations of blood parathyroid Hormone (PTH)
Tijdsspanne: 0, 6 and 12 months
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Serum PTH
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0, 6 and 12 months
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Nutritional status 1: Body weight
Tijdsspanne: 0, 4, 8 and 12 months
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Body weight (in kg)
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0, 4, 8 and 12 months
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Nutritional status 2: waist circumference
Tijdsspanne: 0, 4, 8 and 12 months
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Waist circumference (in cm)
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0, 4, 8 and 12 months
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Nutritional status 3: middle-arm circumference
Tijdsspanne: 0, 4, 8 and 12 months
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Middle-arm circumference (in cm)
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0, 4, 8 and 12 months
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Nutritional status 4: skinfold thickness
Tijdsspanne: 0, 4, 8 and 12 months
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Skinfold thickness (in mm)
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0, 4, 8 and 12 months
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Total consumption of milk and dairy food
Tijdsspanne: 0, 4, 8 and 12 months
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Total consumption of milk and dairy food (in ml/d)
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0, 4, 8 and 12 months
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Consumption of dietary energy
Tijdsspanne: 0, 4, 8 and 12 months
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Consumption of dietary energy (in kcal/d)
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0, 4, 8 and 12 months
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Consumption of dietary protein
Tijdsspanne: 0, 4, 8 and 12 months
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Consumption of dietary protein (in g/d)
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0, 4, 8 and 12 months
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Consumption of dietary calcium
Tijdsspanne: 0, 4, 8 and 12 months
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Consumption of dietary calcium (in mg/d)
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0, 4, 8 and 12 months
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Number of participants with treatment-related adverse events
Tijdsspanne: 0, 4, 8 and 12 months
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Adverse events : assessed by using questionnaires of medical conditions, medications related to milk intake
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0, 4, 8 and 12 months
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Child behaviors
Tijdsspanne: 0 and 12 months
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Child behaviours: assessed by using a Child behavior Questionnaire-- parent version.
The minimum and maximum values: 26-78; higher scores mean worse outcome.
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0 and 12 months
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Physical activity
Tijdsspanne: 0, 4, 8 and 12 months
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Physical activity (in MET, h/week): assessed by a Child Physical Activity Questionnaire
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0, 4, 8 and 12 months
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Concentrations of serum calcium
Tijdsspanne: 0, 6 and 12 months
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Serum calcium (mmol/L)
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0, 6 and 12 months
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Yuming Chen, Ph.D., Sun Yat-sen University
- Studie stoel: Zhifu Zhao, M. Phil, Inner Mongolia Dairy Technology Research Institute Co., Ltd.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
3 september 2021
Primaire voltooiing (Verwacht)
30 oktober 2022
Studie voltooiing (Verwacht)
30 december 2022
Studieregistratiedata
Eerst ingediend
10 september 2021
Eerst ingediend dat voldeed aan de QC-criteria
29 september 2021
Eerst geplaatst (Werkelijk)
12 oktober 2021
Updates van studierecords
Laatste update geplaatst (Werkelijk)
12 oktober 2021
Laatste update ingediend die voldeed aan QC-criteria
29 september 2021
Laatst geverifieerd
1 september 2021
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- SYSU-51000-20210723-0001
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Beschrijving IPD-plan
Published data based on reasonable request.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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