Milk Supplementation and Bone Health in Children
29. september 2021 oppdatert av: 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.
Studieoversikt
Status
Påmelding etter invitasjon
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Forventet)
254
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Gangshu
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Lanzhou, Gangshu, Kina, 730000
- LanZhou University
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
4 år til 6 år (Barn)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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 |
|
Aktiv komparator: 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 |
|
Annen: 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 |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from baseline bone mineral density (BMD) at 12 months
Tidsramme: 0 and 12 months
|
BMD (g/cm2) determined by a dual energy x-ray absorptiometry (DXA) at the left forearm and heel
|
0 and 12 months
|
|
Change from baseline bone mineral density (BMD) at 6 months
Tidsramme: 0 and 6 months
|
BMD (g/cm2) determined by DXA at the left forearm and heel
|
0 and 6 months
|
|
Change from baseline bone mineral contents (BMC) at 12 months
Tidsramme: 0 and 12 months
|
BMC (g) determined by DXA at the left forearm and heel.
|
0 and 12 months
|
|
Change from baseline bone mineral contents (BMC) at 6 months
Tidsramme: 0 and 6 months
|
BMC (g) determined by DXA at the left forearm and heel.
|
0 and 6 months
|
|
Change from baseline of bone-specific alkaline phosphatase at 12 months
Tidsramme: 0 and 12 months
|
Bone turnover marker 1: Bone-specific alkaline phosphatase
|
0 and 12 months
|
|
Change from baseline of bone-specific alkaline phosphatase at 6 months
Tidsramme: 0 and 6 months
|
Bone turnover marker 1: Bone-specific alkaline phosphatase
|
0 and 6 months
|
|
Change from baseline of osteocalcin at 12 months
Tidsramme: 0 and 12 months
|
Bone turnover marker 2: osteocalcin
|
0 and 12 months
|
|
Change from baseline of osteocalcin at 6 months
Tidsramme: 0 and 6 months
|
Bone turnover marker 2: osteocalcin
|
0 and 6 months
|
|
Change from baseline of C-terminal telopeptide of type I collagen at 12 months
Tidsramme: 0 and 12 months
|
Bone turnover marker 3: C-terminal telopeptide of type I collagen
|
0 and 12 months
|
|
Change from baseline of C-terminal telopeptide of type I collagen at 6 months
Tidsramme: 0 and 6 months
|
Bone turnover marker 3: C-terminal telopeptide of type I collagen
|
0 and 6 months
|
|
Change from baseline of tartrate resistant acid phosphatase at 12 months
Tidsramme: 0 and 12 months
|
Bone turnover marker 4: tartrate resistant acid phosphatase
|
0 and 12 months
|
|
Change from baseline of tartrate resistant acid phosphatase at 6 months
Tidsramme: 0 and 6 months
|
Bone turnover marker 4: tartrate resistant acid phosphatase
|
0 and 6 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from baseline body weight at 12 months
Tidsramme: 0 and 12 months
|
Anthropometric indices: body weight
|
0 and 12 months
|
|
Change from baseline body height at 12 months
Tidsramme: 0 and 12 months
|
Anthropometric indices: body height
|
0 and 12 months
|
|
Change from baseline biomarker of body growth at 12 months
Tidsramme: 0 and 12 months
|
Biomarker of body growth: insulin-like growth factor 1
|
0 and 12 months
|
|
Change from baseline immune globulin M (Ig M）at 12 months
Tidsramme: 0 and 12 months
|
Immune status: Blood Ig M
|
0 and 12 months
|
|
Change from baseline immune globulin G (Ig G）at 12 months
Tidsramme: 0 and 12 months
|
Immune status: Blood Ig G
|
0 and 12 months
|
|
Change from baseline immune globulin G (Ig A）at 12 months
Tidsramme: 0 and 12 months
|
Immune status: Blood Ig A
|
0 and 12 months
|
|
Change from baseline whit blood cell at 12 months
Tidsramme: 0 and 12 months
|
Immune status: whit blood cell
|
0 and 12 months
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Concentrations of blood total 25-hydroxide-vitamin D (25-OH-VD)
Tidsramme: 0, 6 and 12 months
|
Serum 25-OH-VD
|
0, 6 and 12 months
|
|
Concentrations of blood parathyroid Hormone (PTH)
Tidsramme: 0, 6 and 12 months
|
Serum PTH
|
0, 6 and 12 months
|
|
Nutritional status 1: Body weight
Tidsramme: 0, 4, 8 and 12 months
|
Body weight (in kg)
|
0, 4, 8 and 12 months
|
|
Nutritional status 2: waist circumference
Tidsramme: 0, 4, 8 and 12 months
|
Waist circumference (in cm)
|
0, 4, 8 and 12 months
|
|
Nutritional status 3: middle-arm circumference
Tidsramme: 0, 4, 8 and 12 months
|
Middle-arm circumference (in cm)
|
0, 4, 8 and 12 months
|
|
Nutritional status 4: skinfold thickness
Tidsramme: 0, 4, 8 and 12 months
|
Skinfold thickness (in mm)
|
0, 4, 8 and 12 months
|
|
Total consumption of milk and dairy food
Tidsramme: 0, 4, 8 and 12 months
|
Total consumption of milk and dairy food (in ml/d)
|
0, 4, 8 and 12 months
|
|
Consumption of dietary energy
Tidsramme: 0, 4, 8 and 12 months
|
Consumption of dietary energy (in kcal/d)
|
0, 4, 8 and 12 months
|
|
Consumption of dietary protein
Tidsramme: 0, 4, 8 and 12 months
|
Consumption of dietary protein (in g/d)
|
0, 4, 8 and 12 months
|
|
Consumption of dietary calcium
Tidsramme: 0, 4, 8 and 12 months
|
Consumption of dietary calcium (in mg/d)
|
0, 4, 8 and 12 months
|
|
Number of participants with treatment-related adverse events
Tidsramme: 0, 4, 8 and 12 months
|
Adverse events : assessed by using questionnaires of medical conditions, medications related to milk intake
|
0, 4, 8 and 12 months
|
|
Child behaviors
Tidsramme: 0 and 12 months
|
Child behaviours: assessed by using a Child behavior Questionnaire-- parent version.
The minimum and maximum values: 26-78; higher scores mean worse outcome.
|
0 and 12 months
|
|
Physical activity
Tidsramme: 0, 4, 8 and 12 months
|
Physical activity (in MET, h/week): assessed by a Child Physical Activity Questionnaire
|
0, 4, 8 and 12 months
|
|
Concentrations of serum calcium
Tidsramme: 0, 6 and 12 months
|
Serum calcium (mmol/L)
|
0, 6 and 12 months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Yuming Chen, Ph.D., Sun Yat-sen University
- Studiestol: Zhifu Zhao, M. Phil, Inner Mongolia Dairy Technology Research Institute Co., Ltd.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
3. september 2021
Primær fullføring (Forventet)
30. oktober 2022
Studiet fullført (Forventet)
30. desember 2022
Datoer for studieregistrering
Først innsendt
10. september 2021
Først innsendt som oppfylte QC-kriteriene
29. september 2021
Først lagt ut (Faktiske)
12. oktober 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
12. oktober 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
29. september 2021
Sist bekreftet
1. september 2021
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- SYSU-51000-20210723-0001
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
Published data based on reasonable request.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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