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Sublingual Glycine vs. Placebo on Attentional Difficulties and Hyperactivity in Prepuberal Children

NCT02655276 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-12-06

No results posted yet for this study

Summary

This study is designed to investigate effects on attentional performance and motoric activity of 100 mg microencapsulated glycine (Bidicin® from Biotiki®) compared to placebo after treatment with t.i.d. sublingual doses over 3 weeks each.

The primary objective of the study is to determine the effects on attentional performance and motoric activity of 100 mg microencapsulated Glycine (Bidicin® from Biotiki® ) compared to placebo after treatment with t.i.d. sublingual doses over 3 weeks each in children with low attentional performance and high motoric activity.

A number of 30 prepuberal boys and girls aged 6 - 14 years with low attentional performance and high motoric activity will be enrolled in this study. The prepuberal status will be determined by Tanner stages ≤ 3.

Conditions

  • Motor Activity
  • Attention Deficit
  • Stress, Psychological

Interventions

OTHER

microencapsulated Glycine

100 mg microencapsulated Glycine (Bidicin® from Biotiki® ) t.i.d.

OTHER

Placebo tablets

Placebo t.i.d. from Biotiki® in a crossover-design.

Sponsors & Collaborators

  • Biotiki

    collaborator UNKNOWN

  • Eberhard Schulz

    lead OTHER

Principal Investigators

  • Eberhard Schulz, Prof. Dr. · University Hospital Freiburg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2016-05-31
Completion
2016-05-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02655276 on ClinicalTrials.gov