Elevated Blood Lead Levels
Conditions
Brief summary
The study is a parallel, randomized, double-blind, placebo controlled clinical trial will evaluate the effect of Lactobacillus plantarum DSM 33464 on reduction of Blood lead levels and general well-being of children.
Interventions
DIETARY_SUPPLEMENTPlacebo
1 sachet of placebo per day for 12 weeks
DIETARY_SUPPLEMENTLactobacillus plantarum DSM 33464
1 sachet SmartGuard® per day for 12 weeks
Sponsors
Beijing Children's Hospital
Baoding Children's Hospital
Xuzhou Children Hospital
Chengdu Women's and Children's Central Hospital
Children's Hospital of Heibei Province
Beijing Clinical Service Center
Novozymes A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
The subjects who meet all of the following selection criteria can participate in this study: 1. Children age 3-12 years 2. BLL 35-249 µg/L 3. Subjects, their parents or legal guardians are able and willing to comply with research guidance 4. Subject's parents or legal guardians sign written informed consent.
Exclusion criteria
Subjects who meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of blood lead levels | 12 weeks | Difference in reduction of blood lead level between the experimental group and the placebo group at week 12 compared with baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of blood lead levels | 4 and 8 weeks | Compared with the baseline, the difference between the reduction of the blood lead level in the experimental group and the placebo group at the 4th and 8th week |
| Reduction of urine lead levels | 4, 8 and 12 weeks | Compared with baseline, the difference between the reduction of urine lead levels in the experimental group and the placebo group at the 4th, 8th, and 12th week |
| Improvement of common trace elements-Ca,Zn,Cu,Mg,Fe in the blood | 4, 8 and 12 weeks | Compared with baseline, the difference between the improvement of common trace elements Ca,Zn,Cu,Mg,Fe in the blood of the experimental group and the placebo group at the 4th, 12th and 24th week |
Countries
China
Outcome results
None listed