Efficacy of Chromium Picolinate in Reducing Acanthosis Nigricans Severity in Adolescents With Insulin Resistance

NCT07371169 | Completed

• 1 other identifier: UU-CR-2025-01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if chromium picolinate can reduce the severity of acanthosis nigricans and improve insulin resistance in adolescents with both conditions. It will also learn about the safety of chromium picolinate use in this age group. The main questions it aims to answer are:

1. 1.Does chromium picolinate reduce the severity of acanthosis nigricans as measured by the Burke quantitative scale for acanthosis nigricans severity in adolescents with insulin resistance?
2. 2.Does chromium picolinate improve insulin resistance as measured by the homeostasis model assessment of insulin resistance (HOMA-IR)?
3. 3.What medical problems do participants have when taking chromium picolinate? Researchers will compare chromium picolinate to placebo to see if chromium picolinate is effective in reducing acanthosis nigricans severity and improving insulin resistance.
4. 4.Take chromium picolinate or placebo daily for 24 weeks.
5. 5.Acquire baseline assessment and then visit the clinic at 8 weeks, 16 weeks, and 24 weeks for clinical evaluation, acanthosis nigricans severity assessment using the Burke quantitative scale for acanthosis nigricans severity, laboratory assessment of insulin resistance using the homeostasis model assessment of insulin resistance, and monitoring for any side effects or complications.

Conditions

Insulin Resistance; Acanthosis Nigricans

Keywords

Chromium Picolinate; Insulin resistance; Acanthosis Nigricans

Outcome Measures

Primary Outcomes (2)

• Change in the clinical severity of Acanthosis Nigricans

  Acanthosis nigricans clinical severity will be measured using Burke's quantitative scale by a trained physician. This scale involves the summation of five parameters representing the severity of Acanthosis Nigricans, which are Neck severity (0-4), Neck texture (0-3), axilla severity (0-4), elbows (0 if Absent, 1 if present), knuckles (0 if Absent, 1 if present), and knees (0 if Absent, 1 if present). The minimum score of this scale is 0, and the maximum is 14. The primary outcome is the difference in acanthosis nigricans severity between the chromium picolinate group and the placebo control group.

  Baseline, 8 weeks, 16 weeks, 24 weeks from enrollment

• Change in the severity of insulin resistance

  The severity of insulin resistance will be measured using the Homeostasis Model Assessment of Insulin Resistance (HOMA-IR), this involves taking a fasting blood sample to measure plasma glucose and serum insulin and applying the formula (HOMA-IR = (Fasting insulin \[µIU/mL\] × Fasting glucose \[mg/dL\]) / 405). The primary outcome is the difference in insulin resistance severity based on HOMA-IR results between the chromium picolinate group and the placebo control group.

  Baseline, 8 weeks, 16 weeks, 24 weeks

Study Arms (2)

Chromium Picolinate

EXPERIMENTAL

Participants in this arm (n=45) will recieve oral Chromium Picolinate 200mcg capsules once daily during the 24-weeks study period.

Drug: Chromium picolinate

Placebo Control

PLACEBO COMPARATOR

Participants in this arm (n=45) will recieve oral placebo capsules matching the shape size and color of Chromium Picolinate, once daily during the 24-weeks study period; they will act as the control group.

Drug: Placebo matching Chromium Picolinate

Interventions

Chromium picolinate DRUG

Chromium Picolinate Cap. 200mcg once daily for 24-weeks.

Chromium Picolinate

Placebo matching Chromium Picolinate DRUG

An inert capsule identical in appearance and packaging to the chromium picolinate 200 microgram capsule (same size, shape, color, weight, and dosing schedule), manufactured without active ingredient. The capsule shell is composed of gelatin or hypromellose, matching the active capsules. The capsule is filled with inert excipients suitable for oral capsules, such as microcrystalline cellulose and magnesium stearate, to replicate the weight and flow properties of the active capsules. Optional coloring agents are included as needed to match the active product. Capsules are packaged in sealed blisters to minimize odor, taste, and visual cues. Dispensed by the investigational pharmacy according to the randomization schedule; to be taken once daily.

Placebo Control

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Adolescent patients of both sexes, aged 12 to 18 years.
• Clinically diagnosed with acanthosis nigricans.
• Present Insulin resistance, defined as Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) ≥ 2.5.
• Willing to participate in the study, with written informed consent provided by both the patient and guardian.

You may not qualify if:

• Diagnosis of type 1 or type 2 diabetes mellitus.
• Known hypersensitivity to chromium or any of the capsule excipients.
• Use of insulin-sensitizing medications (e.g., metformin, thiazolidinediones) within 3 months before screening.
• Use of systemic corticosteroids or other medications known to affect glucose metabolism within 3 months before screening.
• Significant renal disease (estimated glomerular filtration rate \< 60 mL/min/1.73 m²) or liver disease (alanine aminotransferase or aspartate aminotransferase \> 2.5 times the upper limit of normal).
• Pregnancy or lactation.

Sponsors & Collaborators

• Uruk University: lead

Study Sites (1)

Baghdad Medical City / Children Welfare Teaching Hospital / Department of Endocrinology

Baghdad, Baghdad Governorate, 10045, Iraq

Location

MeSH Terms

Conditions

Insulin Resistance; Acanthosis Nigricans

Interventions

picolinic acid

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Melanosis; Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ghasak Kais Abdulhussain, BSc, MSc, PhD (Pharmacology)

  Uruk University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: This is a double-blind study. Participants, and outcome assessors, (Physician and laboratory personnel) will be unaware of treatment assignment. Clinical assessment of acanthosis nigricans severity using the Burke quantitative scale for acanthosis nigricans severity and laboratory assessment of insulin resistance using the homeostasis model assessment of insulin resistance, based on fasting plasma glucose and fasting serum insulin measurements, will be performed without knowledge of treatment allocation. The study medication and placebo will be identical in appearance and packaging. Treatment allocation codes will be securely stored and will be revealed only after completion of data analysis, unless unblinding is required for participant safety.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer in department of Pharmacology (B.Sc , M.Sc, Ph.D) / College of Pharmacy

Study Record Dates

• First Submitted: January 18, 2026
• First Posted: January 27, 2026
• Study Start: January 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: Upon publication of the trial result on open access repository.
• Access Criteria: Access will be open to researchers and the public via a free, open-access data repository, with a DOI provided in the publication. Data will be de-identified to protect participant privacy.

Locations

IR (1)