The Effect of Giving Dates Milk Fortified with Vitamin D Against Vitamin D Status, Calcium and Linear Growth of Children Age 48-59 Month

Phase 3

Recruiting

• Conditions: Children under five are at risk of stunting (HAZ).; Children under five, risk of stunting, vitamin D status, Calcium status, Date-milk Fortified Vitamin D

• Registration Number: TCTR20220727003
• Lead Sponsor: Ministry of Finance

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-27
• Study Completion: 2022-09-20
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

The inclusion criteria of the research subjects were: 1) children aged 48-59 months who were at risk of stunting (HAZ < -1 to -2 SD); 2) serum 25(OH)D < 50 -74 nmol/L; 3) likes to consume milk; 4) do not suffer from lactose intolerance; 5) willing to be a respondent and comply with the rules made during the research and sign the informed consent.

Exclusion Criteria

1) have congenital abnormalities or congenital disabilities; 2) have kidney problems; 3) taking supplements other than those given during the study; 4) did not consume the intervention formula for vitamin D-fortified date milk for seven consecutive days; 5) the subject did not undergo a complete blood test; 6) the subject does not want to continue the research, and 7) subject to change of address.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
An alternative formulation of functional drink dates milk enriched with vitamin D as a drink rich in vitamin D, calcium, zinc and iron for the linear growth of children aged 48-59 months. Two months in phase 2 Analysis of macro and micro nutrients, proximate analysis and organoleptic test questionnaires

Secondary Outcome Measures

Name	Time	Method
Increased levels of serum 25(OH)D, serum calcium procollagen type 1 procollagen type 1 N-terminal (P1NP) and linear growth of children aged 48-59 months. 1 month in the phase 1 survey phase and before and after the intervention phase 3 for 26 weeks Arsenazo III, Ocresolphthalein comlpexon an ELISA